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What is 510k Content Format

This article defines the 510k content format for an FDA 510k pre-market notification submission in accordance with the September 13, 2019, FDA guidance.

image 1 What is 510k Content Format

What is a 510k?

A 510k submission is a pre-market notification submission to the FDA. The “510(k)” designation refers to the applicable section and sub-section of the Food Drug & Cosmetic Act. The “pre-market” designation is a reminder that companies must submit a 510k submission before marketing their products. Finally, the “notification” part of the phrase is used instead of the word “approval” because the FDA does not consider the 510k review process to be an endorsement or approval of your product. Instead, the 510k review process is a review by the FDA to determine if your product meets the requirements of substantial equivalence with a predicate device. The FDA initially performs a prescreening of the 510k submission to verify that it meets the minimum requirements for 510 content format. Then during the 510k substantive review process, the reviewer must answer six questions in the substantial equivalence decision tree:

  1. Is the predicate device legally marketed?
  2. Do the devices have the same intended use?
  3. Do the devices have the same technological characteristics?
  4. Do the different technical characteristics of the devices raise different questions of safety and effectiveness?
  5. Are the methods acceptable?
  6. Do the data demonstrate substantial equivalence?

The 510k process was not intended to be the primary process for regulatory approval by the FDA. The 510k process was intended to be a simplified approach for clearance of devices that are of moderate-risk and similar in design and intended use to another moderate-risk device that is already on the market. However, the process was manipulated as a loophole by device companies to avoid the more rigorous pre-market approval (PMA) process that requires conducting a clinical investigation.

Recent changes to the 510k review process are much deeper than the 510k content format

In approximately 2010, the FDA gradually started making changes to the 510k process. The FDA started publishing more guidance documents specifying both collateral guidance documents that apply to all device classifications (e.g., biocompatibility and human factors ), and particular guidance documents that apply to only a small number of product classifications (e.g., CADe). In 2012, the FDA implemented a new policy called the Refusal to Accept (RTA) Policy for 510(k)s. The FDA implemented this policy to improve the general quality of 510k submissions. All submissions are now subject to a 15-day review of the 510k content format to ensure that the submission includes all 20 required sections required by the FDA, the submission includes a table of contents and page numbering, and the various sections of the 510k include basic elements that are frequently forgotten by companies. Initially, more than 60% of the 510k submissions were rejected during the RTA screening process. Still, submissions have improved, and training of the FDA personnel performing the RTA screening has resulted in a more consistent application of the RTA policy. The FDA also systematically converted each of the remaining Class 3 devices that were eligible for 510k clearance to Class 3 devices requiring a PMA. The most recent changes were the elimination of requiring the submission to include a printed hardcopy of the submission (i.e., FDA eCopy only) and no longer allowing predicates that are more than ten years old.

FDA requirements for 510k Content Format

The FDA requires that your 510k submission is organized into 20 sections as described in section V of the table of contents of the September 13, 2019, FDA 510k guidance document. The FDA no longer requires a hardcopy of the submission. Now the FDA only requires an electronic copy (i.e., FDA eCopy) with a hardcopy of the 510k cover letter. The cover letter may be included in the eCopy, but it is not required. The FDA eCopy guidance document was updated on December 16, 2019.

The FDA eCopy guidance gives you the option of organizing the 20 sections of a 510k into 20 volumes with multiple documents in each volume or to submit sequentially numbered documents. The word “volume” refers to electronic folders in the FDA eCopy rather than physical binders. There is no right or wrong choice regarding volumes—if your eCopy uploads. The answer to this question is personal preference. The FDA recommends that multiple volumes be used for more extensive submissions, but using the same process for every 510(k) submission makes submission teams more efficient. It also is more comfortable for the FDA to navigate between documents when they are not in separate volumes. Therefore, the document structure is generally best for the FDA, and the volume structure is usually best for the company to prevent the need for renumbering files and file names. We always use the volume structure for every submission, even pre-submissions. Submissions are organized into 20 volumes to match the 20 sections of a 510k submission. If we include an RTA Checklist, then we add a 21st volume. The FDA recommends using the 21st volume for miscellaneous appendices, but the volume structure of the submission makes it easy to insert miscellaneous content directly into the applicable sections by adding documents after the initial section summary document.

Overall Numbering or Numbering within Sections?

Again, this is a personal preference. However, there are always last-minute changes to documents. Therefore, whichever numbering system you use should minimize the need for the last-minute renumbering of the entire submission. This is especially painful when you number the overall submission, and then you add a page to the middle of the submission when you are trying to ship out your submission that day. By numbering only the sections, you reduce the amount of rework required. Our firm deviates slightly from the “numbering within sections” requirement. In the table of contents, we indicate how many pages are associated with each document in a volume, and then we start each document with page 1. One FDA reviewer recently requested that we modify this to “page x of y,” where “x” is the page number of that document, and “y” is the total number of pages in the document. Therefore, we updated all of our templates to reflect the “page x of y” format for page numbering.

510k Format Content: Using Your Table of Contents for Project Management

When I was less experienced, I used project management software and action item lists to manage submission projects. Experience has taught me to simplify. Now I only use an action item list to track the progress of individual tasks. To track the overall submission, I now use the table of contents as my project management “report.” If you color-code the rows of your table of contents, you can communicate the status of each document in the submission. At the beginning of the project, all the rows indicate documents are not yet started—signified by the color red. Once I being a document, I change the color to yellow. Finally, when the document is completed, I change the color of the row to green. Three documents require the signature of the official correspondent with the FDA:

  1. 510k Cover Letter
  2. Certification Regarding Confidentiality
  3. Truthful and Accuracy Statement

Once these three documents are completed, they still need a signature that should only be applied just before we prepare the eCopy. Therefore, I signify the status of documents waiting for signatures with blue rows. A couple of people struggle with reformatting row colors, but every single person on your team will understand that they want the table of contents to gradually change from red, to yellow and finally to 100% green.

Posted in: 510(k)

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NSE letter: A CAPA plan for your 510k process

Cry, complain, call the reviewer…you might feel a little better, but you received an NSE letter, and tomorrow you still can’t sell your device.

NSE Letter NSE letter: A CAPA plan for your 510k process

Instead, try approaching an NSE letter like a CAPA investigation. What is the issue? The FDA determined that your device is not substantially equivalent to the predicate you selected. What is the root cause? There are four (4) possible root causes.

NSE Letter Cause #1: You failed to verify that the predicate is a legally marketed device.

If your predicate device is not legally marketed, you need to select a new predicate and resubmit. However, it is doubtful that your device would pass the refusal to accept the (RTA) screening process if the predicate was not legally marketed. If your predicate was not registered and listed with the FDA (check using this link), then you should have submitted a pre-sub request to determine if the agency has any problem with using the device you chose as a predicate. This is an essential question if the manufacturer is no longer in business, and the product is no longer for sale.

NSE Letter Cause #2: You failed to evaluate the substantial equivalence of your device’s intended use with the predicate.

The intended use of your predicate device is documented for every potential predicate since February 1992 on FDA Form 3881–which you can download along with the 510(k) clearance letter for the predicate. There is also an intended use documented for every device category in the applicable regulation for that device. This intended use is more generic than FDA Form 3881, but both are applicable. The FDA Form 3881 you submit for your device must be equivalent. I recommend a point-by-point comparison with regard to the following elements: 1) OTC vs. prescription use, 2) user, 3) patient population, 4) illness or medical condition, 5) duration of use, 6) environment of use and 7) target part of the body. Any difference can raise new issues of risk and may result in an NSE decision. However, the FDA typically will work with the company to modify the wording of FDA Form 3881 to ensure the intended use is equivalent or to make sure you provide clinical evidence to address the differences. In my pre-submission requests, I include a comparison document for the intended use to ensure that the FDA is aware of any differences in the intended use.

Cause #3: You failed to convince the FDA that technological differences do not raise different questions of safety and effectiveness.

Unless your device is identical in every way to the predicate device, you will have to persuade the FDA that differences do not raise questions of safety and effectiveness. At the beginning of the 510(k) process, it is helpful to document technological differences systematically. Specifically, this should include: 1) materials, 2) design, 3) energy source, and 4) other features. For each difference, you must justify why the difference does not raise different issues, or you must provide data to prove it. It is also possible that you were not aware of questions of safety and performance raised by technological differences. To avoid this problem, you can submit a detailed device description and draft labeling to the FDA in a pre-sub meeting request. If you ask questions about differences in a pre-sub meeting, you can avoid an NSE letter.

Cause #4: You failed to provide data demonstrating equivalence.

For each difference, you should determine an objective method for demonstrating that the difference is equivalent in safety and performance to the predicate. Your test method can be proposed to the FDA in a pre-sub request before testing. The FDA sees more than 3,000 companies propose testing methods to demonstrate equivalence each year. They have more experience than you do. Ask them in a pre-sub before you test anything. There may be a better test method, or you might need to adjust your test method. Sometimes results are unclear, but there might be another test you can perform to demonstrate equivalence, and then you can resubmit your 510(k). Possibly you were unaware of the need to perform a test, and you were unable to complete a test within the 180 days the FDA allowed for submitting additional information. The good news is you now have all the time you need.

What is similar between all four causes of the NSE letter?

In all four root causes identified above, you could benefit greatly from the pre-sub meeting. Now you have an NSE letter, and you know which of the four reasons why your submission did not result in 510(k) clearance. However, the correction to your NSE letter may not be clear. Therefore, you should consider requesting a pre-sub meeting as quickly as you can. Most companies choose not to submit a pre-sub meeting request because they don’t want to wait 60-75 days. However, sometimes pre-sub meetings are scheduled sooner. In addition, 60-75 days is not as costly as receiving a second NSE letter.

Prevent a future NSE letter by requesting a pre-sub meeting

Regardless of your corrections for the current NSE letter, you should prevent future occurrences by planning to submit a pre-sub meeting request for every submission. I try to help clients gather all the information they need without a pre-sub meeting, but each new 510(k) reminds me why a pre-sub meeting is so valuable. You always learn something that helps you with the preparation of your 510(k).

Help with Pre-sub meeting requests

The FDA published a guidance document for pre-sub meeting requests. If you need additional help, there is a webinar on this topic.

Posted in: 510(k), CAPA, Design Control

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Reprocessed Single-Use Devices – Optimizing 510(k) preparation

This article explains the challenges reprocessors face in obtaining 510(k) clearance for reprocessed single-use devices when they are not the OEM.

Guidance for Reprocessed Single Use Devices Reprocessed Single Use Devices   Optimizing 510(k) preparation

With increasing pressures on the medical device industry to make healthcare more affordable, there has been a push to reprocess and reuse single-use devices. Reprocessors obtain used devices from healthcare facilities. The reprocessors clean, process, resterilize, repackage, and relabel devices. Reprocessors must obtain FDA 510(k) clearance by demonstrating that the safety and effectiveness of the reprocessed device are substantially equivalent to the single-use device produced by the original equipment manufacturer (OEM). The FDA also released a guidance document regarding reprocessed single-use devices.

Obtaining 510(k) clearance for a device your company did not design can be challenging because information requirements that are trivial for the OEM can be extremely difficult to provide for a reprocessor of the device. The following sections of a 510(k) submission pose unique challenges for reprocessed single-use devices:

Section 13, Labeling of reprocessed devices

Labeling of reprocessed devices consists of the instructions for use and the packaging label(s). Device package labeling may also direct the user to both the reprocessor’s IFU and the OEM’s IFU. If you are referencing the OEM’s IFU, it is also important to include the OEM’s model number. Instructions for use should consist of:

  1. Indications for use, which must be equivalent to the OEM indications.
  2. All of the necessary warnings and cautions and basic operating instructions needed to operate the device safely.
  3. The instructions for use may also instruct the user to reference the OEM instructions for use for additional information.
  4. Instructions on the handling of the device after use, with the likelihood that the device will be returned to the reprocessor to repeat the cycle.

Section 15, Biocompatibility

Biocompatibility data is more challenging to provide if you replace or modify original components. If reprocessing does not modify the OEM device whatsoever, you can claim that the materials are identical to the OEM device. Therefore, the reprocessed device does not require biocompatibility testing. However, the reprocessor still needs to evaluate the biological risks associated with the reprocessing of the device by testing for cleaning and sterilization residuals. This involves testing for cleaning agent residuals and EO residual testing (ISO 10993-7), if applicable.

If you replace any of the components during reprocessing, with a new component that is identical in dimension and material to the OEM component, minimal biocompatibility testing will be required. If the exact material used by the OEM is unknown, reprocessors can perform material identification testing to determine the material used, and then create the replacement part out of the same material.

If you modify or replace any patient-contacting components on the device such as lubricants, insulation, etc., with components that are different from the OEM, then you will need to perform additional biocompatibility testing to prove that the new or modified material is biocompatible. This testing will depend on the duration of contact and where will the material contact the patient. The new material will also need to be listed in your device description and Section 15 of your 510(k) submission.  

Section 18, Performance Testing

There are three primary sources for identifying performance testing requirements of reprocessed devices:

  1. OEM Testing listed in the OEM 510(k) submission
  2. Predicate Testing listed by another reprocessor of an equivalent device
  3. Product Standards listed under the product classification code for the reprocessed device or the OEM device

You should reference a predicate device that has been reprocessed and the OEM device to identify performance testing. Some testing is specific to the functional performance of the device. For these tests, you need to compare performance side-by-side against the OEM. Another testing is specific to the reprocessing, and you will reference the predicate device. Sources of information regarding the required tests for each of these devices can be found in the 510(k) summaries of the respective devices. If possible, it’s helpful to select a predicate that has a redacted 510(k) available on the FDA’s website. If a redacted 510(K) is not readily available, you may request a redacted copy through the freedom of information act on-line. A redacted copy of the OEM 510(k) is also helpful.

If testing information is not as readily available in the 510(k) summary, you will determine the essential performance functions of the device, and design tests to evaluate and compare the OEM device and the reprocessed device for those functionalities. Some devices have specific standards for the design and/or testing of the device. To determine if the reprocessed device has any applicable standards, you should search the product code of the reprocessed device, as well as the product code of the OEM device if they are different, in the FDA product classification database. Recognized standards applicable to the reprocessed device will be listed in the search results.

Additional tests that may be needed to validate reprocessing include residual protein, residual carbohydrates, and the presence of hemoglobin. These tests ensure that all biological material from previous use is removed. If you are not performing biocompatibility testing on the reprocessed device, you also need to do a chemical test to ensure no residual detergent or cleaning residues are remaining on the device. You also need to determine how many reprocessing cycles the device can survive before performance degradation. This can be done by repeating simulated use, reprocessing, and performance testing until a statistically relevant decrease in the performance of the device is observed.

If you have additional questions regarding the preparation of your 510(k) submission, you might be interested in a course Mary Vater and Rob Packard created for AAMI. Rob Packard will be the lead instructor for the course pilot in May: 510(k) training course. You can also schedule a call with us by clicking the button below.

Click here to schedule a 15 minute call 300x62 Reprocessed Single Use Devices   Optimizing 510(k) preparation

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eCopy Guidance is Finally Updated by FDA

This blog summarizes the changes in FDA policy, which was released on April 27, 2020, as a new eCopy guidance for device manufacturers.

eCopy statement screen capture eCopy Guidance is Finally Updated by FDA

The date of the guidance above was updated, but the changes to the guidance do not represent any changes in policy. It is an update of contact information and a note regarding eCopies for EUA requests. In August 2016, I had a frustrating week where I had three (3) different submissions placed on eCopy hold by the FDA, three (3) separate times, for a total of nine (9) eCopy hold in the same week. That resulted in an extra $175 of FedEx charges and wasted six (6) USB flash drives. The biggest problem was the submission delay experienced by each of our clients that week, and it wasn’t very comfortable. This terrible, no good, dreadful week ultimately resulted in our company creating a new productized service–preparing FDA eCopies for clients and competitor consultants. We also became international experts on the FDA eCopy guidance. I figured if my experience was this painful, there must be other people that were experiencing the same problem, or many people would experience this problem as soon as they tried to submit their next filing with the FDA.

For about 18 months, we helped a lot of companies prepare FDA eCopy submissions, but then there was a government shutdown, and the FDA unofficially changed their policy. A printed paper copy of pre-submissions, 510ks, and De Novo classification requests would no longer be required. You only needed to print a paper copy of your cover letter and include an electronic copy on a CD, DVD, or USB flash drive. Despite this change in policy, many clients still requested the printed copy, because the FDA legislation was not yet changed, and there was not updated guidance. We explained to each client that the policy had changed, and only two clients asked us to print the paper copy anyway.

In the fall of 2018, the unofficial policy became official, but there was still no updated FDA eCopy guidance for us to refer clients to. This situation frequency resulted in questions from clients about how they should phrase the “eCopy Statement” in their submission cover letter. The eCopy guidance that was current in 2018 stated that you should include the following phrase in your cover letter: “This submission includes an eCopy and a paper copy. The eCopy is an exact duplicate of the paper copy.” However, the paper copy consisted only of the cover letter, and the rest of the submission was solely being provided in electronic format.

The FDA released a new pilot version of the eSubmitter software to help companies prepare 510(k) submissions and to streamline the FDA review of submissions in 2018. However, even electronic submissions prepared with eSubmitter still have to be sent by courier or mail to the FDA Document Center. In 2019, the FDA mentioned that they would be releasing new guidance documents regarding electronic submissions. Still, we were also told that the FDA has no near-term plans to enable companies to submit pre-submissions, 510ks, or De Novo classification requests to the FDA via an electronic submissions gateway (ESG).

Finally, on December 16, 2019, the FDA released a new eCopy guidance. The eCopy guidance was updated again on April 27, 2020, but the changes are updated to include emails, updated webpages, and a note regarding EUA requests.

What DID NOT change in the new eCopy guidance?

The file name requirements are identical. You can still organize your submission in volume structure or document-only structure. You are still limited to PDF file sizes of 50 MB. The eCopy will still be problematic for the FDA to upload if your submission exceeds 1 GB. You still need to ship your eCopy to the FDA Document Center, unless you are submitting to CBER instead of CDRH. You can and should continue to use the eCopy validation software module provided by the FDA to ensure that your eCopy will properly upload. The guidance barely even changed in length; it’s just a few pages shorter now.

What DID change in the new eCopy guidance?

Only two things changed in the new guidance. First, there is no mention of an eCopy statement anywhere. Second, you are required to submit a cover letter in paper format, but it does not need to be included in the electronic format (that’s only recommended).

The “new” eCopy process is not any easier than the process we have been using since February 2018. However, we did update our cover letter template. If you would like a copy, please register for our FDA eCopy webinar.

Should you create your own eCopies, or should you outsource?

If my job was Director of Regulatory Affairs (or a similar position), I would definitely outsource. Regulatory managers in companies are swamped with trying to remain compliant with every applicable medical device regulation, every change to applicable standards, and one hour of your time is a lot more important to your boss than $150.

Does it take one hour to create an eCopy?

No, we can prepare, validate, and ship your eCopy in less than 15 minutes. This is only possible because we do this almost every single day of the week, and we are located only 4 miles from a FedEx full-service office with a 6:25 pm cut-off for drop-off. On the last business day before the end of the FDA fiscal year, we average four (4) submissions on that day alone. We know exactly what to do, we know how to fix all of the most common errors, we know our validation software module is up-to-date, and we never run out of USB flash drives.

How long could it take you to create an eCopy?

If you haven’t done an eCopy in that past year, it could easily take you all day to create an eCopy. You have to read the new eCopy guidance document. You need to format your submission according to the rules and proof-read 100% of the folder and file names. You need to find a new flash drive. You need to save the submission on your USB flash drive. You need to run the eCopy validation software module. You need to read my blog about how to eliminate hidden system volume information folders created by Microsoft Windows 10. You figure out how to find the Command Prompt on your computer. You need to eliminate the hidden folder. You need to re-validate the electronic copy. You need to eject the USB (don’t accidentally re-insert it for any reason). Then you need to download my template for a cover letter, create your cover letter, and sign the cover letter. Then you need to find a FedEx envelope, find the company’s FedEx account number, complete the shipping label, and package up your FedEx envelope. If you’re lucky, you have regular pick-ups scheduled each day, and you finished just-in-time. For 80% of you, you will need to look-up the nearest FedEx dropbox and drive there like a crazed maniac and try to avoid getting a speeding ticket.

Or you could just outsource your eCopy problems.  

Posted in: 510(k)

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Alternate 510k Pathway – Safety and Performance Based Pathway

Today the FDA released a press release announcing plans to implement an alternate 510k pathway called the “Safety and Performance Based Pathway.”

Alternate 510k Pathway Safety and Performance Based Pathway Alternate 510k Pathway   Safety and Performance Based Pathway

What is the current 510k pathway for clearance of medical devices?

The current version of the 510k pathway is defined in a guidance document on a substantial equivalence that was released on July 28, 2014. The pathway involves six questions that an FDA reviewer must answer before it can be determined whether a new device is equivalent to an existing device that is legally marketed in the USA. These are the six questions:

  1. Is the predicate device legally marketed?
  2. Do the devices have the same intended use?
  3. Do the devices have the same technological characteristics?
  4. Do different technological characteristics raise different questions of safety and effectiveness?
  5. Are the methods of evaluating new/different characteristics acceptable?
  6. Does the data demonstrate substantial equivalence?

Five (5) ways the FDA strengthened the current 510k pathway

Today the FDA released an 8-page presentation summarizing five (5) ways that the FDA strengthened the current 510k pathway during the past several years. The five ways are:

  1. Increased expectations for the content of a 510k submission
  2. Implementation of the refusal to Accept (RTA) policy
  3. Improved consistency and thoroughness of the 510k review process
  4. Elimination of the 510k pathway for Class III devices
  5. Eliminated the use of > 1,000 unsafe devices as legal predicates

You may have been complaining that 510k requirements seem to change constantly. Now you have proof that the changes to the 510k pathway are part of a strategic plan implemented over the past decade. Lawyers may argue that the resulting regulations go well beyond the intent of the original 510k legislation. This is completely true. The cumulative effect of implementing dozens of 510k guidance documents is that the official interpretation of the 510k section of the Food and Drug Act now has little resemblance to the original legal intent.

The original intent of the 510k legislation was to allow competitors to copy an existing device that is legally marketed in the USA. Cumulative changes to a device that existed in 1976, eventually result in a completely new device. The word “equivalent” has been perverted to such an extent that thousands of devices now exist that do not even remotely resemble devices from 1976. The FDA recognized this around 2007, and the US device regulations began to “strengthen.”  

What is the basis for the Alternate 510k Pathway?

The basis for the alternate 510k pathway is the submission of data that is safety and performance-based instead of comparison to an older predicate. In addition, the new pathway will enable you to make comparative claims by demonstrating that the new subject device meets or exceeds the safety and performance criteria. There is also a goal to use the pathway as a potential method of harmonizing the US medical device regulatory process with other global medical device regulations. The new process, combined with improved post-market surveillance, will complement the FDA’s work on NEST by allowing the FDA to rapidly require the implementation of risk controls to address identified safety issues.

What is the expected timeline for the implementation of the Alternate 510k Pathway?

The alternate 510k pathway has been in development for quite some time. Jeff Shuren first announced the plan to create the alternate 510k pathway at AdvaMed’s MedTech conference in San Jose, California, in September 2017. On Monday, December 11, 2017, the FDA announced that draft guidance would be released in Q1 of 2018. On April 12, 2018, the FDA finally released the draft guidance for public comment.

The FDA intends to release final guidance for the new alternate 510k pathway in early 2019. This pathway will initially be limited to “well-understood device types”–probably as a 510k pilot program. You can expect this new pathway to be released in a similar way to the Special 510k expansion pilot and the Quik 510k pilot. That final guidance will be released, and the pilot will begin immediately after the release of the guidance.

Is this new process likely to require significant changes to future 510k submissions?

The phrase “significant changes” is subjective, but if you look at the current 20 required sections of a 510(k) submission, there is only one section that would be required to change for the new alternate 510k pathway. Specifically, section 12 is currently used for a substantial equivalence comparison. This section would not be applicable under the alternate 510k pathway. Under the alternate 510k pathway, you can expect the FDA to require at least a summary of the safety and performance data to be submitted for approval of the subject device.

Another change you can expect is that all devices submitted under the alternate 510k pathway will be required to have a benefit-risk analysis in accordance with the corresponding FDA guidance. This new guidance was released on September 25, 2018, as a draft. However, a benefit-risk analysis is required for De Novo applications, CE Marking applications, and, logically, the FDA will also require this for 510k submissions that do not rely upon equivalence to the predicate device.

More Information on the Medical Device Safety Action Plan

The FDA created a webpage on its site, providing information about the Medical Device Safety Action Plan. The page includes several hyperlinks to documents with more information. Below are a few of the relevant links:

The FDA also indicated that a new guidance for De Novo applications would be released in a couple of weeks. Please subscribe to our blog, and you will receive notification of a blog in response to that guidance when it is released.

Posted in: 510(k)

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Quik 510k Pilot – Explanation of Quik 510k Pilot

There are 38 product classification codes that the FDA selected for the Quik 510k Pilot program to evaluate version 3 of the eSubmitter software.

510k Quik Pilot Product Codes 1 Quik 510k Pilot   Explanation of Quik 510k Pilot

What are the three (3) advantages of the new Quik 510k pilot program?

There are three (3) advantages of using the eSubmitter software as part of the Quik 510k pilot.  The first advantage of using the eSubmitter software is that the refusal to accept (RTA) process will be eliminated. This change is enormous because nearly 50% of submissions are rejected during the RTA screening process. The hope is that the eSubmitter software will prevent companies from submitting submissions that are missing required content, and therefore the RTA process will not be needed. However, we have seen many submissions placed on hold for technicalities rather than sub-standard submissions. Consequently, it will be fascinating to see the FDA reported outcomes from the Quik 510k pilot.

The second advantage of using the eSubmitter software is that the reviews will be interactive. This means that reviewers are not expected to have any additional information (AI) requests. This also means that submitters will need to respond to questions from reviewers quickly. For example, I have received a call on Friday afternoon after 5:00 pm EDT asking if I could revise to document and email that document to the reviewer by Monday morning. This is an extreme example, but 48-72 hours is typical for a required turn-around during interactive reviews.

The third advantage of using the eSubmitter software is that the FDA is targeting completion of their 510k review within 60 days. This 30-day reduction may seem huge, but the FDA already cut 15 days off its review timeline by eliminating the RTA screening. Second, the FDA picked 38 product classification codes that should not have difficulty reviewing in 60 days. Not all product classifications have the same amount of testing data required, and I do not expect the FDA to be able to review all product classification codes in 60 days–even with eSubmitter.

Although the Quik 510k pilot mentioned that submissions would be zipped, eSubmitter is also designed for electronic submissions through an electronic submissions gateway (ESG). An ESG has the added advantage that you will not need to ship your submission via FedEx. This advantage will gain you only a maximum of 24 hours, but I wish I had those 24 hours last week. Every year, in the last week of September, all the small businesses with small business qualifications try to submit their 510k before the end of the fiscal year (i.e., September 30). This year I had four clients that were in this position. One was unable to get the data they needed to complete their submission before September 30. The other three were making last-minute changes up until the afternoon of Thursday, September 27. One of those submissions was extremely challenging because the submission included video files that exceeded 1GB in total. Therefore, I called CDRH’s eCopy Program Coordinators at 240-402-3717. They were accommodating. They said that it would be best to provide two identical eCopies or to save the MISC FILES and STATISTICAL DATA folders on a separate flash drive. The reason for this is that very large submissions can take days to upload into the CDRH database. Therefore, the picture below shows you what my final solution was for the three submissions this week. The De Novo submission had to be split.

20180927 121031 Quik 510k Pilot   Explanation of Quik 510k Pilot

What our firm has done to take advantage of the Quik 510k pilot

If you have a product with any of the 38 product classification codes listed above, and you need to submit a 510k in the next six months, you are very fortunate. The FDA will prioritize your submission, and you are likely to be able to get your device cleared in 60 days or less. Our firm is very anxious to take part in this pilot because the FDA intends to require the eSubmitter software for all submissions in the future, and we expect other product classification codes to be added to the pilot over time. We process dozens of 510k submissions each year, and mastering the nuances of the software is critical to our continued success. I already downloaded the software and installed it onto my computer. I also created a complete submission as a test. eSubmitter saved several hours in the preparation of a 510(k) from the typical 40 hours the process takes. Therefore, I expect the implementation of new eSubmitter software to a triple win for the FDA, clients, and our firm. I plan to request that the FDA add De Novo submissions next to this pilot. The reason is that De Novo submissions typically have more content, and the content is more variable. I think this would be an extremely challenging test for eSubmitter, and the relatively small volume of De Novo submissions would limit the impact upon FDA resources.

Changes to eCopy Requirements in 2018

In 2017, the FDA indicated that eSubmitter software was going to be revised, and it would be approximately two years before companies would be able to submit a 510k electronically to the FDA. Until then, companies must ship an electronic eCopy and a paper copy to the FDA Document Control Center (DCC). The eCopy guidance states, “An eCopy is accompanied by a paper copy of the signed cover letter and the complete paper submission.” However, the FDA’s eCopy guidance has not been updated since December 3, 2015. There are some unofficial changes to the policy, and the FDA no longer requires the complete paper submission. Instead, you can submit an eCopy accompanied by a paper copy of the signed cover letter.

Before February 2018, we would print 1,000+ pages for each 510k submission, pack two 3” three-ring binders in 12”x12”x6” ULine boxes and ship the box to the FDA overnight via FedEx. We typically would charge $400 for this eCopy service. After the unofficial policy change, all of our 510k submissions consist of a paper copy of the cover letter and an eCopy on a USB flash drive. We only charge $150 for the FDA eCopy service, and 100% of our eCopy submissions have been uploaded without problems this year.

What is the difference between creating an eCopy and submitting it with eSubmitter (cited from FDA website)?

There are four differences between eSubmitter and eCopies:

  1. An eSubmission package contains PDF attachments and XML file types. The XML files are intended for CDRH IT systems to process the application. Reviewers will not see these XML files. 
  2. The parts of the eCopy guidance that describe the structure of a 510(k) submission will not apply to the Quik Review Program Pilot.
  3. An eSubmission is organized according to the layout of the template, which places administrative documents (e.g., Form 3674, the 510(k) Summary, the Truthful and Accurate statement) at the end of the submission because their applicability is determined based on the answers to questions in the body of the template (e.g., Form 3674 is only required if the applicant indicates clinical data are included).
  4. Electronic signatures are used in the submission (e.g., on the Truthful and Accurate statement), rather than physical signatures.

eSubmitter Template Options

For device 510k submissions, the FDA’s eSubmitter gives you three options:

  1. Template Version 1.3, for In Vitro Diagnostic 510k submissions to CDRH only, allows you to create a 510k submission and the eSubmitter software will package your submission in a specially formatted zip folder that you can save to a compact disc (CD), digital video disc (DVD) or flash drive. Then you must print a paper copy of your signed cover letter and ship the eCopy created by eSubmitter with your paper copy of the cover letter to the FDA DCC.
  2. Template Version 1.2.1, for Non-In Vitro Diagnostic 510k submissions that are among the 1,000+ other product classifications not included in the Quik 510k pilot (CDRH: Medical Device eCopies), you can create a 510k submission and the eSubmitter software will package your submission in a folder for you. You can then copy the contents of that folder to a compact disc (CD), digital video disc (DVD), or flash drive. Then you must print a paper copy of your signed cover letter and ship the eCopy created by eSubmitter with your paper copy of the cover letter to the FDA DCC.
  3. Template Version 3.2, for Non-In Vitro Diagnostic 510k submissions that are among the 38 product classification codes that are listed above for the Quik 510k pilot program. This allows you to create a 510k submission, and the eSubmitter software will package your submission in a specially formatted zip folder that you can save to a compact disc (CD), digital video disc (DVD), or flash drive. Then you must print a paper copy of your signed cover letter and ship the eCopy created by eSubmitter with your paper copy of the cover letter to the FDA DCC. This template is unique to the Quik 510k pilot program. There is a red bar that appears at the top of the screen:

“This template should only be used to construct a submission if you are submitting it as part of the Quick Review Pilot. All others may use the content of this template as a reference to aid in constructing an eCopy. If you are not part of the Quick Review Pilot, do not construct a submission with this template, it will be rejected.”

When you create your eCopy, then you will need to create a volume-based or non-volume based submission in accordance with the eCopy guidance. The volume folders and/or files are saved to a compact disc (CD), digital video disc (DVD), or flash drive. Then you must print a paper copy of your signed cover letter and ship the eCopy you created with your paper copy of the cover letter to the FDA DCC.

Warning Symbol Quik 510k Pilot   Explanation of Quik 510k PilotWarning: If you are using Windows 10, and you save your eCopy or eSubmitter zip folder on a flash drive, Windows 10 will automatically create a hidden system folder titled “System Information Volume.”  This folder is created as a security feature to enable you to recover accidentally deleted content. However, this folder results in an error when the FDA attempts to upload your submission automatically. Therefore, you must remove this hidden system folder. Instructions for this can be found on our website page about eCopy hidden system files.

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Third party review of 510(k) submissions – When it makes sense and which third party to choose?

third party review Third party review of 510(k) submissions – When it makes sense and which third party to choose?

What is a Third Party Review?

A third-party review is the review of a 510(k) that has been submitted directly to a third party rather than the FDA themselves. Back in 1997, as part of the FDA Modernization Act or FDAMA, the ‘Accredited Persons Program’ was created. This allowed the FDA to accredit persons, or ‘third parties’ to conduct the primary review of certain 510(k) submissions. One of the goals of this program was to be able to make the submission and review process faster and more efficient.

The third-party review is not a full alternative to submitting a 510(k) to the FDA. Third parties are authorized by the FDA to conduct the primary review of specific types of devices only. Only certain devices are eligible for third party review. The FDA keeps a database of those devices here in one of their medical devices databases (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm).

The use of a third party review also does not bypass the FDA. The third party is only conducting the primary review of the 510(k) and then forwarding the submission, the review of the submission, and the post review recommendation to the FDA. The FDA then has a 30-day timeline to issue a final determination of the submission.

How many 510(k) submissions use a third-party review?

In 2016, I did an analysis of 510(k) submissions reviewed by the general and plastic surgery panel. I reviewed submissions that received clearance between January 1, 2015, and August 10, 2016. Of the 690 510(k) clearances that were issued by the panel, only nine (9) were submitted for third party review. Although third party reviewers were responsible for only 1.3% of the submissions I reviewed, there are other device classifications with higher percentages of reviews being conducted by third-party reviewers. There were a total of 114 submissions that were issued 510(k) clearance through a third-party review process during that period.

For this article, I reviewed the 3,023 510(k) clearances that were issued in the past 12 months (i.e., May 23, 2016, through May 23, 2017). Only 75 of the 510(k) submissions issued (2.5%) were submitted for third party review. Of these 75 submissions, the average review time by the FDA (after the third party review is completed) was 46 days. Since the average review time for the FDA of a traditional 510(k) is 183 days (based upon my data analysis from 2016), third party review can potentially reduce your 510(k) clearance timeline by months.

Why do only 2.5% of 510(k) submitters utilize a third-party review?

Originally, my theory was that only a limited number of product classification codes are eligible for third party review. The FDA is trying to expand the third-party review program, but 44% of third party reviews are for the radiology panel. Another 13% were for the general hospital panel, and 13% more of the reviews were for the cardiovascular panel. Finally, less than 7% were reviewed for the dental panel. The remaining 17 submissions were reviewed for other panels. A closer look at the product classification codes shows that there are only a few product codes within these panels that are being reviewed by third parties.

I also had a second theory for why so few submitters are using third parties. As I reviewed the actual 510(k) summaries for these 75 submissions, I noticed there were only four (4) companies listed as third party reviewers in the last 12 months:

  1. Regulatory Technology Services, LLC (http://www.markjob.com/) = 56 submissions
  2. Third Party Review Group, LLC (http://www.fdathirdpartyreview.com/) = 15 submissions
  3. TUV SUD America, Inc. (http://www.tuv-sud-america.com) = 3 submissions
  4. Center for Measurement Standards of Industrial in Taiwan = 1 submission

2018 Updated- FDA’s reporting of the first three quarters of 2018

Compared with the above information, the first three-quarter reportings for 2018 list a total of more third party reviewers. Currently, in the quarterly reports from the FDA, there are the following 3rd party reviewers:

  1. AABB = 5 or less
  2. Center for Measurement Standards of Industrial (CMSI) = five or less
  3. New York State Department of Health (NYSDOH) = five or less
  4. Nordic Institute of Dental Materials (NIOM) = five or less
  5. Regulatory Technology Services, LLC. (RTS) = 36
  6. Third Party Review Group, LLC. (TPRG) = 13
  7. TUV SUD America, INC. (TUV) = 5 or less

The FDA keeps an up to list of approved third-party reviewers under the Medical Devices Databases. Titled Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997- (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfthirdparty/Accredit.CFM?party_key=8).

As of Quarter Three, there have been a total of 53  Third Party 510(k) Submissions Accepted. A majority of these completed by Regulatory Technology Services, LLC, and Third Party Review Group, LLC (TPRG). 36, and 13, respectively. All of the others have five or less, but these numbers may increase once the fourth-quarter report is released.

When should you choose a third-party review instead of submitting directly to the FDA?

Always check the 510(k) database to see if third party reviewers were used for your product’s classification code. Ideally, a third-party reviewer has been involved in a device that is in the same product classification, and possibly that device would be a suitable predicate for you to select for your 510(k) submission. If your search yields no results, your device may not be eligible for a third party review. However, you can always contact one of the four third party reviewers listed above.

In general, the third-party review process is an excellent way to shorten your 510(k) clearance timeline by months. The cost is significantly more than the FDA user fee. However, a faster time to market is almost always worth the increased fee. Therefore, if a third party review is available, I recommend taking advantage of this option.

Do you need help?

Medical Device Academy offers a regulatory pathway analysis service for $1,500. For those of you that are only interested in the US market, rather than including the EU and Canada, the cost for this service is only $750. Do you need help identifying the product classification for your device, determining the required performance testing, and selecting a predicate device? We can do this for you in one week or less. Do you need an expedited review? We can also determine if your product is eligible for third party review and obtain a quote for you.

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Are 510k pre-sub meetings a waste of time?

This article reviews four of the top reasons for why other companies feel requesting 510k pre-sub meetings is a waste of time, but you can’t afford to.

Requesting 510k pre sub meeting is a waste of time 1024x448 Are 510k pre sub meetings a waste of time?

It only takes my team 8-10 hours to prepare a 510k pre-sub request. The FDA does not charge you a cent for requesting 510k pre-sub meetings, and a pre-sub should be part of every design plan. But most companies are resistant to requesting 510k pre-sub meetings. Here are the top 4 reasons why companies tell me they don’t need to request a meeting:

It’s too late for requesting 510k pre-sub meetings

If you are less than a week away from submitting a 510k, it is too late for requesting 510k pre-sub meetings. The FDA target for scheduling a 510k pre-sub meeting is 60-75 days from the date your request was submitted. That’s 10-11 weeks. Most companies tell me that they plan to submit a 510k within weeks or a couple of months, but most of the companies take several months, and frequently there is a delay that requires six months or more. For example, what if your device fails EMC testing, and you have to change the design and retest for both EMC and electrical safety? At best, you will have an 8-week delay. If you submit a request next week, and everything goes as you plan, you can always withdraw your request for the pre-sub. If you encounter a delay for any reason, suddenly, it’s not too late.

Our design is not finalized yet

I believe that waiting until your design is almost complete is the number one reason why companies wait too long to request 510k pre-sub meetings. If they wait too long, then the previous reason for not requesting a meeting takes over. The ideal time to submit a pre-sub request is 75 days before you approve your design outputs (i.e., design freeze). However, very few people are precise in their design planning and execution. You should try to target sometime after you approve your design inputs, but before you approve your design outputs. As long as you submit an update to your pre-sub request two weeks before the meeting, the FDA will accept it. Also, you can always schedule a date that is later than 75 days if you realize you requested the meeting too early.

We don’t want to be bound by what the FDA says in the 510k pre-sub meeting

510k pre-sub meetings are “non-binding.” That means that the FDA can change their mind, but it also means you don’t have to do everything the FDA says in a 510k pre-sub meeting. If you don’t ask a question about testing requirements, that doesn’t mean that the FDA does not have any testing requirements. The FDA knows what previous companies have submitted for testing better than you do, and they may be in the process of evaluating a draft special controls guidance. If you ask questions, you will have better insights into what the FDA expects. Understanding FDA expectations helps you write better rationales for testing or test avoidance. You also might learn about deadlines for the implementation of new testing requirements that you might be able to avoid. Finally, you can ask the FDA about possible testing options you are considering if the FDA denies your most optimistic testing plans.

There is already a guidance document for our device

Not all device classifications have a guidance document explaining what information should be submitted in a pre-market 510k submission. However, there almost one hundred Class II Special Controls Guidance Documents. Therefore, there is a good chance that the FDA published special controls as part of the regulation for your device or as a guidance document. As part of the special controls, the FDA defines what performance testing is required for your device. If you already know what testing is required, then the value in requesting 510k pre-sub meetings is diminished. But at least three other key benefits remain.

First, you can verify that the predicate you plan to use for comparative testing is not going to be a problem. Although the FDA can’t tell you which predicate to pick, the FDA can tell you if there is a problem with the predicate you have selected. This is especially important if the product is not currently registered and listed, because you may not know if the device was withdrawn from the market after it was cleared.

Second, not all testing standards are prescriptive. Many tests have testing options that require you to make a decision. Input from the FDA may be valuable in making choices between various performance testing options. Sometimes you even forgo testing and provide a rationale instead. FDA feedback on any rationale for not doing testing is critical to prevent delays and requests for additional information later.

Third, there are many different FDA representatives that participate in 510k pre-sub meetings. The lead reviewer will invite specialists and the branch chief to the meeting. Each of these specialists can answer questions during a pre-submission meeting that they are not able to answer during the actual review process. You also have the opportunity to get feedback from the branch chief–who has insight from all the previous devices that were cleared with your product classification. Your lead reviewer is not likely to be as experienced as the branch chief, and may only have been working at the FDA for months. Your request for the 510k pre-sub meeting will help an inexperienced lead reviewer as much as it will help your company.

Learning More about 510k Pre-sub Meetings

On Thursday, February 22, there will be a free webinar offered on the topic of 510k pre-sub meetings. We had 50 people register for the webinar on the first day it was announced, and we have already answered more than a dozen related questions. If you are planning to submit a 510k this year, this webinar will show you exactly how to prepare your request for a 510k pre-sub. You will even receive copies of all of our templates for free.Stop wasting time and register now Are 510k pre sub meetings a waste of time?

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Biocompatibility testing questions answered in pre-submission requests

This article is a copy of my responses to someone that submitted biocompatibility testing questions in preparation for a 510k pre-submission webinar.

510k pre submission webinar February 22 for LinkedIn.jpg 1024x459 Biocompatibility testing questions answered in pre submission requests

Can you please answer the following questions related to biocompatibility for a 510k pre-submission meeting request?

This was the request by a person that registered for a 510k pre-submission webinar that was recorded in February 2018. The person asked some great questions that are very similar to other clients I work with. They also requested the biocompatibility testing questions in a way that did not divulge any confidential information–other than to indicate they live in Germany. Therefore, I am sharing my email response with you. Please register for this webinar and submit your questions. Questions are entered in an open text box, and you have room to ask multiple questions.

Biocompatibility testing question #1: Does the FDA now already ask for the AET (Analytical evaluation threshold) for chemical analyses?

This is exactly the type of biocompatibility testing questions you should be asking in a 510k pre-submission meeting. If you ask, “What biocompatibility testing is required for a 510k?” You will only receive a reference to the FDA guidance for biocompatibility. A better approach is to ask a biocompatibility testing lab to provide a Biological Evaluation Plan (BEP). Then you can submit your plan as part of the 510k pre-submission meeting request and include this question regarding the section of the BEP where you explain how you intend to perform chemical characterization of your device and how you intend to determine whether the materials represent risks related to sub-acute toxicity and sub-chronic toxicity endpoints.

Biocompatibility testing question #2: How can I avoid time-consuming genotoxicity studies for FDA?

Typically if you perform the “Big 3” (i.e., cytotoxicity, irritation, and sensitization), and then you perform chemical characterization, you are often able to prepare a Biological Evaluation Report to explain why there are no identified compounds in the chemical characterization that would warrant performing the genotoxicity studies. This is also often true for acute toxicity testing and sub-chronic toxicity testing. This often saves > $10K. To verify the FDA will accept this approach, you will typically provide a biological evaluation plan (BEP) as part of your pre-submission request. Your biocompatibility testing questions should specifically reference your BEP.

Question #3: And how can I face FDA with a cytotoxic wound dressing but which passed irritation, sensitization, genotox, and pyrogenicity tests?

I had a product that contained aluminum. Aluminum is cytotoxic to the cell line that is used in the cytotoxicity testing. However, aluminum does not have a high level of toxicity for the route of administration for that product. You should identify the reason why your product is cytotoxic and then explain why the device is no toxic for the intended use and duration of contact. This would normally be part of that BEP mentioned above.

Biocompatibility testing question #4: Which genotoxicity tests are state of the art for the FDA?

There are three ways to determine that. One is to look in the recognized standards database on the FDA website. The second is to review the FDA guidance on biocompatibility and application of ISO 10993-1. Finally, you can ask the FDA about the suitability of another test you want to perform during a pre-sub. If they prefer a different test, they will say so in an email response, and they are available for discussion by conference call during the pre-sub meeting to clarify their response.
I did not answer this question outright, because biocompatibility requirements change over time. This is also true for other verification testing standards. In fact, for one 510k project, I had seven different standards change just before submission. During a pre-submission meeting, the FDA should make you aware of coming changes to these tests. Also, better biocompatibility testing labs are aware of the changes before they are implemented. This is because the lab managers participate in the committees that revise and update international standards.

Will the meeting be recorded since I live in Germany?

Yes, all of my webinars are recorded. You will receive an email with a link for downloading the recording within 24 hours of completing the original live webinar or at the time of purchase if you are purchasing one of our previously recorded webinars. You can also schedule calls with me as a follow-up using the following link: http://calendly.com/13485cert/30min.

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MDUFA IV – FDA User Fee Increase – Strategic Implications

This article identifies the strategic implications of the FDA user fee increases resulting from MDUFA IV starting in FY 2018.

FY 2018 MDUFA Fees MDUFA IV   FDA User Fee Increase   Strategic Implications

You didn’t know the FDA user fee increased?

In August, the FDA publishes the new FDA user fee schedule for the next fiscal year, which begins on October 1. Last year the FDA published an updated small business guidance document in early August that included the fee schedule. This year, the release of the FY 2018 FDA user fee schedule was delayed until the end of August, because the re-authorization of user fees was not approved until August 18, 2017.

The MDUFA IV user fee schedule was negotiated in October of 2016, and the new user fee schedule proposed to increase the user fees to $999.5 million. That negotiated plan called for an increase in standard fees for 510k submissions while keeping small business fees lower. The final enacted MDUFA IV user fees follow this plan. There is a significant difference between PMA fees and 510k fees in the new fee schedule. There was a 33% increase for all PMA-related standard and small business fees. However, standard 510k fees increased by 125%, while small business fees for a 510k increased by 13%. The establishment registration fees increased by 37%, and there is still no discounted registration fee for small businesses. Finally, the biggest change is there will now be a fee for De Novo applications.

Implications of the De Novo FDA user fee increase

Congress authorized the MDUFA III fees in 2012 for five years, and there were no fees associated with De Novo applications. In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) also streamlined the De Novo application process. The purpose of having no fees, and for streamlining the process, was to encourage medical device innovation. However, only 40% of De Novo application reviews were completed within 150 days during 2015 and 2016. The balance of the applications required 200 to 600+ days to complete. Negotiations between the FDA and industry in 2016 resulted in an agreement to trade an increase in FDA user fees for a decrease in the review time required for 510k clearance. However, the FDA also committed to decreasing the De Novo application review time to less than 150 days as follows:

De Novo application decision goals for MDUFA IV 1024x118 MDUFA IV   FDA User Fee Increase   Strategic Implications
Unfortunately, the agreed FDA user fee for De Novo applications in MDUFA IV for FY 2018 is $93,229 as a standard fee and $23,307 for small businesses. During the past five years, during MDUFA III, companies that felt they had a potential De Novo application would try to persuade the FDA that a borderline 510k submission should be a De Novo application instead. However, under MDUFA IV, you will be more likely to persuade the FDA that a borderline classification should be considered for a 510k submission instead of a De Novo application.

Also, you should plan your De Novo application more carefully than you might have for a free application. Pre-submission meeting requests should always be submitted during the development process, and these pre-sub requests should be submitted at least 90 days before your design freeze. Special consideration should also be devoted to risk analysis and gathering preliminary data to demonstrate the effectiveness of the risk controls you select to ensure that the clinical benefits of your device outweigh the residual risks of the device after implementing risk controls. Ideally, you will gather enough evidence to create a draft special controls guidance document to submit to the FDA as a supplement to your pre-submission meeting.

If you are planning a De Novo application for FY 2018, you should expect your FDA reviewer to pay special attention to ensuring that there are no unnecessary delays in the review process. You should also monitor the FDA’s new final guidance webpage for the release of a final guidance document for De Novo applications. The draft guidance was released on August 14, 2014. Creating final guidance will probably be a priority for FY 2018.

Implications of the 510k FDA user fee increase

The standard FDA user fee for a 510k increased 125% from $4,690 to $10,566. However, the absolute dollar amount of a 510k submission is still less than the cost of biocompatibility testing or sterilization validation. Therefore, the increase should not significantly decrease the number of submissions. However, the small business fee has only been increased by 13%. Therefore, if you are a small business (i.e., income < $100 million), you should complete an application for small business qualification as soon as you can (i.e., October 1, 2017) to make sure that you are eligible for the discounted fee when you submit your next 510k submission. If you need help preparing your small business qualification form, there will be a webinar on this topic Friday, September 8, 2017.

When you are planning a 510k submission, you should also determine if your device product classification is eligible for third party review. In the past, the increased cost of the third party review made submission of a 510k to a third party reviewer unattractive. However, the fees for third-party reviews range from $9,000 to $12,000 typically. Therefore, there may be no difference in the fee for a third party review unless your company is a qualified small business.

Implications of MDUFA IV FDA user fee increase

The increase in the annual establishment registration fee is 37% for medical device firms to $4,624. If you are already registered as a medical device firm, you should increase your annual budget for the establishment registration fee accordingly. If you are about to launch a new product, remember that you are required to register and list your product within 30 days of distribution of your product. Therefore, if shipments are going to begin in September, you don’t need to register until October (i.e., after the start of the new fiscal year). Therefore, you may be able to avoid paying the FY 2017 establishment registration and only pay the FY 2018 establishment registration. This would not be the case for foreign firms that need to import the product prior to distribution.

What you can do about MDUFA IV fee increases now.

You may not be able to change the user fee schedule for FY 2018, but there are three things you can do now to improve your situation. First, if you are a small business, you can speak to your accounting department and get them to provide a copy of the FY 2016 tax return so that you can complete the small business qualification form on October 1. Second, you should contact Regulatory Technology Services and the Third Party Review Group to obtain a quote for a third-party review of your 510k submission instead of submitting directly to the FDA. Third, you should add a reminder to your calendar for August 1, 2018, to start reviewing the FDA website and other sources for an FY 2019 FDA user fee schedule.

Learning how to submit a small business qualification form

If you have not completed a small business qualification form before, you can learn how to prepare your application for small business qualification by registering for my webinar on Friday, September 8, 2017.

Posted in: 510(k), FDA

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