Archive for 510(k)

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 6 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 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 that 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 2 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 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 your most optimistic testing plans are denied by the FDA.

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 in 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 own 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

The following is a copy of my responses to someone that submitted biocompatibility testing questions in preparation for the 510k pre-submission webinar that I am hosting Thursday, February 22 @ 4pm EST.

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

Can you please answer the following biocompatibility testing questions?

This was the request by a person that registered for my live webinar next Thursday. The person asked some great questions that are very similar to other clients I work with. They also asked 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 own questions. Questions are entered in an open text box, and you have room to ask multiple questions.

1. Does the FDA now already ask for the AET (Analytical evaluation threshold) for chemical analyses?

I’m not an analytical chemist. That would be an awesome question for Thor Rollins at Nelson Labs. He is giving a 1-day workshop on bicompatibility testing on March 20:
Nelson Labs is offering a 1-day seminar the day before the 510(k) workshop on biocompatibility ($499):


2. How can I avoid time consuming genotox studies for FDA?

Typically if you perform the “Big 3” (i.e., cytotox, 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 genotox studies. This is also often true for the acute toxicity testing and sub-chronic toxicity testing. In order to verify the FDA will accept this approach, you will typically provide a biological evaluation plan (BEP) as part of your pre-submission request. This often saves > $10K.


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 provide an explanation why the device is no toxic for the intended use and duration of contact. This would normally be part of that BEP mentioned above.


4. Which genotox 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. 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.


Note: I did not answer this question outright, because biocompatibility testing (and all verification testing) requirements change over time. In fact, for one 510k project I had 7 different standards change just prior to submission. During a pre-submission meeting, the FDA should make you aware of coming changes to these tests. Also, the better biocompatibility testing labs, such as Nelson Labs, are also aware of the changes before they are implemented. This is because personnel like Thor Rollins personally get involved in the revision of standards.


5. Will the meeting be recorded since I live in Germany?
Yes, all of my webinars are recorded. I will email you a link for downloading it and you will receive that email in the morning after the webinar. You can also schedule calls with me as a follow-up using the following link:



Future Related Events

In addition to the 1-day seminar by Thor Rollins on biocompatibility testing (March 20), we are also offering a 2-day 510k workshop at the same Embassy Suites Hotel in Las Vegas. The cost is $995 (discount for multiple attendees). Here’s the link for registration–or email and I can invoice your company.

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FDA User Fee Increase for FY 2018 – Strategic Implications

This article identifies strategic implications of the FDA user fee increase for FY 2018 that was published by the FDA last week.

FY 2018 MDUFA Fees FDA User Fee Increase for FY 2018   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 follows 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 FDA User Fee Increase for FY 2018   Strategic Implications
Unfortunately, the agreed FDA user fee for De Novo applications in MDUFA IV for FY 2018 are $93,229 as a standard fee and $23,307 for small businesses. During the past 5 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.

In addition, 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 prior to 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 recent final guidance webpage for release of a final guidance document for De Novo applications. The draft guidance was released on August 14, 2014. Creating a final guidance will probably be 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 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, its possible that there may be no difference in the fee for a third party review unless your company is a qualified small business.

Implications of establishment registration 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 the FDA user fee increase 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 a 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.

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510k Design Control Requirements and 510k Risk Management Requirements

This article reviews 510k design control and risk management requirements when compared with your design history file (DHF) and your risk management file.

Design Controls and Risk Management 510k Design Control Requirements and 510k Risk Management Requirements

Last week I presented a free webinar on how to combine Risk Management with Design Controls, when planning to submit a 510k. There were many questions about what design history file (DHF) and risk management file (RMF) documents are required for a 510k. There is no specific part of the the regulations stating what the 510k design control requirements are. However, certain elements of the DHF are required as 510k design control documentation, but not necessarily in the exact form as maintained in the DHF. For example, Design Inputs and Design Outputs are presented as applicable recognized standards and design specifications, while others will remain exactly the same (i.e., verification and validation test reports).

For Risk Management, the only submissions that require inclusion of risk documentation are devices containing software of at least moderate level risk. There are some exceptions to this as well though, based on a few special control guidance documents—especially when the submission type is an abbreviated 510k. This is article identifies which of the DHF and RMF elements are 510k design control requirements and 510k risk management requirements.

510k Design Control Requirements

Design Controls are identified in 21 CFR 820.30. Every manufacturer of any class II or class III devices, and certain class I devices (class I devices with software, tracheobronchial suction catheters, surgeon gloves, protective restraints, radionuclide applicators, radionuclide teletherapy devices) need to control design per this regulation. The requirement for a Design History File is item j) and states:

“Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.”

The “requirements of this part” refers to the other bullets in 21 CFR 820.30 which can be summarized as:

a) Establish and maintain procedures to control design of device.

b) Design and Development Planning – Each manufacturer shall establish a plan that describes the design and development activities, and defines responsibilities for implementation.

c) Design Inputs – Manufacturers need to ensure design requirements relating to a device are appropriate and address the intended use of the device.

d) Design Outputs – Design outputs need to be documented in terms that allow an adequate evaluation of conformance to design input requirements. Design outputs that are essential for the proper functioning of the device should be identified.

e) Design Review – Formal documented reviews of design results should be planned and conducted at appropriate stages of device development.

f) Design Verification – Design verification confirms that the design output meets the design inputs requirements.

g) Design Validation – Design validation shall be performed under defined operating conditions on initial production units or their equivalents, and shall ensure that devices conform to defined user needs and meet the intended use of the device.

h) Design Transfer – Design transfer documentation shall ensure that the device design is correctly translated into production specifications.

i) Design Changes – changes should be identified, documented, validated/verified, reviewed and approved before their implementation.

The Design History File is intended to be a repository of the records required to demonstrate compliance with your design plan and design control procedures. While companies are required to create, and maintain this documentation according to the FDA regulation, not all of the documentation will be reviewed as part of the 510k. The following table compares the elements that comprise a DHF with the 510k design control requirements.

DHF Element 510k Design Control Requirements
Design Plan Not Required
User Needs Not Required
Design Inputs

Cover Sheet (Section 1) and

Declaration of Conformity (Section 9)


Some design inputs will appear in the form of standards in FDA Form 3514 (Cover Sheet) and in the Declaration of Conformity FDA Form 3654 (Standards Data Report)

Design Outputs

Device Description (Section 11)


The Device Description lists the specifications of the device, and your Design Outputs document will help populate the Device Description. This can include drawings, pictures, or written specifications that describe your device.


Proposed Labeling (Section 13)

The labeling is usually considered part of the Design Outputs within the DHF, and is included specifically in the labeling section of the 510(k) submission. This includes both the Instructions for Use and any Package Labeling.

Verification and Validation Protocols

Not Required


You do not have to include the protocols, but the reviewer may ask to see them if they have any questions when reviewing the reports.

Verification and Validation Reports

Sterilization (Section 14)

Biocompatibility (Section 15)

Software (Section 16)

Electrical Safety and EMC (Section 17)

Bench Performance Testing (Section 18)

Animal Performance Testing (Section 19)

Clinical Performance Testing (Section 20)


Of course, not all of these sections will be applicable for every device, but you should include all relevant validation test reports within your submission in the appropriate section of the 510k. Typically, each of these sections will have a cover sheet that outlines the reports that are included within the section, and then you can just include the report from the DHF in its entirety behind the cover sheet in that section.

Process Validation Only required for sterilization validation typically, but there are exceptions for novel materials and coatings
Work Instructions Not Required for 510k
Design Review Meeting Minutes Not Required for 510k
Design Trace Matrix Only required for software
Risk Management File Sometimes – See Risk Management File Table Below
Post-Market Surveillance Plan Not Required, but a few exceptions for high risk devices
Clinical Data Summary Required only if used to demonstrate safety and efficacy
Regulatory Approval Will result from 510k Clearance, so nothing to be included in 510k submission.

510k Risk Management Requirements

Regarding the FDA regulations for risk management, there is a requirement under the Design Validation section of 21 CFR 820.30 that states:

“Design validation shall include software validation and risk analysis, where appropriate.”

For the purposes of FDA compliance and CE Marking, both recognize ISO 14971 as the standard for risk management. FDA recognizes ISO 14971:2007 whereas EN ISO 14971:2012 is the European National version for CE Marking. Rob Packard wrote an article describing the contents of the risk management file as well as the specific differences in the requirements between the FDA and CE Marking with regard to ISO 14971.

For the purposes of your 510k submission, the FDA only requires risk management documentation to be included if the product contains software and the risk is at least a level of “moderate concern”. There are some other cases when risk management is required by special controls guidance documents, but even when it is required you only have to submit your risk analysis. The table below describes the risk management requirements in greater detail.

RMF Element 510k Risk Management Requirement
Risk Management Plan Not Required
Hazard Identification

510ks with Software Only (Section 16)


Hazard Identification is only required for devices that have a software component. It is not required for most other devices.

Risk Assessment

510(k)s with Software (Section 16)

Certain Special Controls Guidance


The Risk Assessment is only required to be included if your device contains software, or if a special controls guidance document specifically requires risk assessment. It is not required for other 510ks.

Risk Control Option Analysis Software and Certain Special Controls Guidance
Risk Control Verification and Validation

Sterilization (Section 14)

Biocompatibility (Section 15)

Software (Section 16)

Electrical Safety and EMC (Section 17)

Bench Performance Testing (Section 18)

Animal Performance Testing (Section 19)

Clinical Performance Testing (Section 20)


This will not be any additional or special documentation specific to Risk Management, and was already included in the DHF breakdown above, but the verification and validation also relate back to risk management in ensuring that the risks have been adequately mitigated.

Risk Benefit Analysis

Not Required for 510(k)


Risk Benefit analyses are only required for De Novo applications, Humanitarian Device Exemptions and PMAs.

Informing Users and Patients of Risks

Labeling (Section 13)


Part of the risk management will appear in the Labeling section of the 510k as warnings, contraindications, and precautions within the Instructions for Use and Package Labeling.

Risk Management Report Not Required

Your first step in preparing your 510k submission is to search the FDA Guidance Document Database to determine if there is an applicable guidance document for your device. You can read another blog we wrote to explain Special Controls Guidance documents, and how to determine if one is applicable to your device. The following list provides examples of Class II Special Controls Guidance documents that require risk analysis to be included within the 510k:

When there are 510k risk management requirements, the special controls guidance document will typically state, “We recommend that the summary report contain:

An identification of the Risk Analysis method(s) used to assess the risk profile in general as well as the specific device’s design and the results of this analysis. (Refer to Section 6 for the risks to health generally associated with the use of this device that FDA has identified.)

Discussion of the device characteristics that address the risks identified in this class II special controls guidance document, as well as any additional risks identified in your risk analysis.”

The special controls guidance will also identify risks to health that have been identified for products of that type, which you should be sure to include in your risk analysis as appropriate.

More information on 510k design control & risk Management requirements

Hopefully, you are now able to determine which elements of your DHF are 510k design control requirements and which elements of your RMF are 510k risk management requirements. If you would like more information about how to implement design controls and risk management within your product development process, please register for our free webinar. If you need any further information or specific assistance with your 510k submission, please feel free to send me an email at or schedule a call with our principal consultant, Rob Packard who can answer any of your medical device regulatory questions.

Click here to schedule a 15 minute call 300x62 510k Design Control Requirements and 510k Risk Management Requirements

Posted in: 510(k), Design Control, Risk Management

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Reprocessed Single-Use Devices: Considerations for a 510k Submission

This is blog entry summarizing an article published on the FDAeCopy website about the unique challenges of 510k submissions for reprocessed devices.

FDA eCopy Blog Abstract Reprocessed Single Use Devices: Considerations for a 510k Submission

Mary Vater joined Medical Device Academy as a new regulatory consultant in March 2017. She published her first new blog on our FDA eCopy website today. The blog explains the unique challenges of reprocessed single-use devices when preparing a 510k submission.

Challenges of 510k Submissions for reprocessed devices

There are three areas in particular that challenge reprocessors when preparing a 510k submission for reprocessed single-use devices:

  1. Section 13, labeling
  2. Section 15, biocompatiblity
  3. Section 18, performance testing

In her article, Mary reviews each of these sections of a 510k submission and identifies both pitfalls and solutions for testing requirements in each of the sections of a 510k.

One of the most important things to know when preparing a 510k submission for a reprocessed device, is whether you need to perform any biocompatibility testing at all. Biocompatibility testing is one of the longest verification and validation tests–as well as the most costly. If you do not modify the device during reprocessing, then you don’t need to perform biocompatibility testing. This article reviews the types of modifications that will require biocompatibility testing.

You also need to develop your own instructions for use and labeling for reprocessed devices. You can reference the original equipment manufacturer’s (OEM) IFU, but you there is specific information needed for reprocessed devices that should be included. This information includes the name and model number of the OEM device.

Finally, it is not enough to provide performance testing data showing that after reprocessing a device it remains equivalent to the OEM device. You must show that the performance remains equivalent after multiple reprocessing cycles. Most devices will deteriorate over time and may only be able to survive a certain number of reprocessing cycles. This testing data needs to be included in your 510k submission.

If you are interested in learning more about how to prepare a 510(k) for a reprocessed single-use device, please visit the FDA eCopy website.

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Redacted 510k Database – Have you used the newest FDA tool?

This article describes the new database of redacted 510k submissions that was recently made available on-line for immediate download by the US FDA.

Number of Redacted 510k Available Since November 2000 Redacted 510k Database   Have you used the newest FDA tool?

Recently the FDA made redacted 510k submissions that were previously released through Freedom of Information Act (FOIA) requests available on-line for immediate download. There are 496 redacted 510k submissions available since November 2000–as indicated by the graph above. This is only a small fraction of the total number of 510k submissions, but the number that are available on-line will increase over time.

Types of redacted 510k Submissions

Of the 496 submissions there is a mixture of submission types.

  • 382 are traditional 510k submissions
  • 97 are special 510k submissions
  • 17 are abbreviated 510k submissions
  • 14 were 3rd Party reviewed

What remains in a redacted 510k submission

The redacted versions do not include testing data, but you will find other goodies such as:

  • 3rd Party SE memorandums (where applicable)
  • Table of Contents
  • Pre-market Notification Cover Sheet (i.e., FDA Form 3514)
  • 510k Cover Letter
  • Indications for Use (i.e., FDA Form 3881)
  • 510(k) Summary
  • Truthful & Accuracy Statement
  • Device Description
  • Executive Summary
  • Substantial Equivalence Discussion (Partially Redacted)
  • Summary of Biocompatibility Testing (Partially Redacted)
  • Summary of Sterilization & Shelf-Life (Partially Redacted)
  • Proposed Labeling
  • Predicate Device Labeling
  • Declarations of Conformity (i.e., FDA Form 3654)
  • Deficiency Letter

This is extremely valuable information that can be used to help select a potential predicate and to develop a verification and validation testing plan. If you are less experienced in the preparation of a 510k submission it will help to see how other regulatory experts have organized their own 510k submissions.

Learning more about redacted 510k submissions

In order to access this database, click on this link: Redacted FOIA 510k Database. In order to limit your search to only 510k submissions that are available as a redacted full 510k, just click on the box for “Redacted FOIA 510k.” If you are interested in learning more about how to make the most of this new resource, please sign up for my new webinar on Monday, November 21 @ 9am EST.

Posted in: 510(k)

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Abbreviated 510k or Traditional 510k, which should you choose?

This article briefly explains the three types of 510k submissions and identifies when you should be submitting an abbreviated 510k instead of a traditional 510k.

Abbreviated 510k Abbreviated 510k or Traditional 510k, which should you choose?Three types of 510k submissions

The FDA has three different target timelines for reviewing a 510k submission and issuing a decision regarding substantial equivalence (i.e., SE Letter):

  1. Special 510k
  2. Abbreviated 510k
  3. Traditional 510k

Special 510k submissions

The first type is a special 510k submission. The FDA target timeline for a special 510k is 30 days, but you can only submit a Special 510k for a modification of your own device that already has a 510k issued. In addition, a Special 510k is only possible if the device modification requires a single technical discipline to review the change. For example, changes to software and materials requires a review of software validation and biocompatibility. Therefore, two reviewer specialists must coordinate their efforts and the review cannot be completed in 30 days. In this case an abbreviated or traditional 510k must be submitted instead.

Abbreviated 510k submissions

The second type of 510k submission is an abbreviated 510k. The FDA target timeline for review is 60 days. If there is a recognized standard specific to the type of device you are submitting, or the FDA has issued a guidance document addressing that device classification, then an abbreviated 510k submission is recommended. For example, a dental handpiece (i.e., product code is ) has a special controls guidance document that written specifically for dental handpieces and the guidance states that an abbreviated 510k submission is recommended. In addition, the FDA recognizes the latest standard for dental handpieces: ISO 14457:2012 (FDA Doc # 4-206).

Traditional 510k submissions

The third type of 510k submission is a traditional 510k submission. The FDA target timeline for review is 90 days. If you are submitting a 510k for a new device, or the device modifications require more than one functional area of expertise, then a special 510k is not an option. If there is no recognized standard for the device type and the FDA has not issued a special controls guidance for your device classification, then an abbreviated submission is also not an option. A traditional 510k submission is your only option in this case.

How frequently is an abbreviated 510k submission type used?

In September 2016 there were 260 510k SE decisions issued by the FDA. Here’s the breakdown by type:

  • Special 510k – 47 submissions = 18%
  • Abbreviated 510k – 8 submissions = 3%
  • Traditional 510k – 205 submissions = 79%

In general, I think it requires a little more effort to write clear and concise summaries for the various sections of an abbreviated 510k than it does for a traditional 510k. But if you can get your product to market a month quicker then it’s worth it.

Posted in: 510(k)

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Two New Live 510k Webinars – October 14, 2016

On October 14, 2016 I will be be presenting two new live 510k Webinars for the cost of $29.

Two Live 510k Webinars Two New Live 510k Webinars   October 14, 2016

Where to register for live 510k webinars

I hope you can participate in these live webinars, but all my webinars are recorded and you will receive a link to download the recording if you are registered for the live event. Have a great weekend!

Posted in: 510(k)

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Product Launch in 300 Days: 3x 100 Days – Design, 510k and QMS

This article explains the process and major milestones for completing a new medical device product launch in 300 days–including the product design, 510k clearance and quality system implementation.

Device Product Launch in 300 Days Product Launch in 300 Days: 3x 100 Days   Design, 510k and QMS

One of the most valuable pieces of information you can receive is a plan for your medical device product launch. Some companies contact me asking for help implementing their quality system. You should be implementing this step last if you are a start-up company. Some companies contact me asking for help preparing their 510k submission. But you need to seek help much earlier. The best time to contact an expert for help with your product launch is 300 days before you want to actually launch your product.

Three Major Milestones of a Product Launch

There are three major milestones that must be completed before a medical device product launch can proceed. First, you need to complete the design specifications for your device. Second, you need to complete the design verification and validation activities and summarize this testing in a 510k submission or another type of regulatory submission. Third, you need to implement a quality system that meets the requirements of 21 CFR 820 and/or ISO 13485:2016. Each of these three major tasks can be completed in less than 6 months, but with proper planning and motivation all three can be completed sequentially in less than one year for many products. In fact, completing all three milestones in 300 days is possible.

Break Your Product Launch into Phases

Whenever I plan a design project I break the overall product development into chunks that are easily understood, with measurable milestones and I establish a timeline that is aggressive but possible. The design process typically has six phases, but several of these phases are shorter than you really want and the overall process is too long for a single chunk. Therefore, I decided to break the six phases into 3 chunks: 1) product development, 2) verification and validation, and 3) regulatory clearance. The end of the first chunk is marked by a “design freeze” where your team will conduct a design review and approve the final design outputs before you begin verification and validation of your product design. The second chunk is marked by the submission of a 510k or some other regulatory submission. The third chunk is marked by the completion of your quality system and receipt of your 510k clearance letter from the FDA.

How Long Should Each Phase of the Product Launch Be?

In the past I would choose a timeline of approximately 3-4 months for each major phase of product launch. However, I have been learning a lot about goal setting and I now target 100 days for completion of most milestones. The reason is that 100 days is a time period over which most people can maintain their enthusiasm and motivation for completing a goal. If a goal takes longer than 100 days, then you should probably break down the goal into two or more smaller goals. If each of the three major phases of your product launch require 100 days, then you can complete the overall product development and product launch within 300 days. One of the tools I recommend for planning and tracking your progress toward a 100 day goal is: The Freedom Journal.

Product Launch Phase 1 – Your Design Plan

Your design plan should be the first thing you create. In order to create a design plan you will need to identify the regulatory pathway–including all of the testing that is required for verification and validation of your new medical device. This design plan should identify all the design reviews, all the verification and validation testing that is required and the regulatory approval process required prior to product launch.

Product Launch Phase 2 – Preparing Your 510k Submission

Once you have approved your design outputs during the “design freeze,” now you need to complete the verification and validation testing. During this phase you will need to make sure that you have identified all the testing, how many samples will be required for each test and you need to determine which steps of the testing process can be performed in parallel instead of performing tasks in series. For example, you will need to package and sterilize samples that are needed for biocompatibility testing, but electrical safety testing samples can be non-sterile. Therefore, the packaging validation must be completed prior to biocompatibility testing, but the electrical safety and EMC testing can be performed in parallel with both activities. For most products, the biocompatibility testing is one of the last tests that is typically completed, and the longest of these tests typically takes between 8-12 weeks. Therefore, 100 days is probably the fastest you can complete your verification and validation testing. During the entire verification and validation process you should be preparing your 510k submission. This will ensure that the submission is ready when the last test report is received–instead of frantically rushing to complete the submission in just a few weeks at the end of the process.

Product Launch Phase 3 – Implementing Your Quality System

Many companies start their quality system at the beginning of the design process. However, you should only implement two procedures prior to completing your 510k submission: 1) design controls, and 2) risk management. These two procedures are needed to properly document your design history file (DHF), and it is much harder to document your DHF after the design is completed. The balance of the procedures can be implemented in about 100 days, while your 510k submission should take between 90 and 180 days to receive clearance from the FDA. Therefore, you should be able to complete the quality system implementation prior to receipt of your 510k clearance letter.

“Rinse and Repeat” for Your Next Product Launch

Once your have completed your product launch, you should review the post-market surveillance of from your customers during the first 90 days. I like to call this the 100-day review. One-hundred days after the first product launch is the perfect time to conduct your first management review meeting. You should have your first internal audit completed during the first 100 days and you should have a lot of great feedback from customers during the first 90 days of product use. Therefore, top management can review the customer feedback, internal audit results and progress toward other quality objectives in order to identify improvement action items needed. These improvements may be quality system improvements and/or product improvements. One of the outputs of your first management review meeting should also be identification of your next product development.

Posted in: 510(k)

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eCopy Hidden System Files Created by Windows 10 Updates

This article explains how to debug problems created by Windows 10 updates which automatically create eCopy hidden system files.

ecopy replacement for 510k submission 1024x422 eCopy Hidden System Files Created by Windows 10 Updates

The above picture is a USB flash drive with a replacement ecopy for a recent 510k submission I worked on. A couple of weeks ago, one of these little USB flash drives and the Microsoft Corporation conspired to create one of the most creative riddles I have ever solved in my entire life.

How do you delete a file you can see?

Not just any old hidden file, but a hidden system file called: “IndexerVolumeGuid.”

ecopy Hidden System Files

IndexerVolumeGuid is a special system file that was on my brand new USB flash drive in the System Volume Information Folder. This file keeps an index of the files in the System Volume Information Folder. Your computer can use that index to recover accidentally deleted information. Normally this is a useful and desirable feature, but I purchased my brand new USB flash drive to send an eCopy 510k submission to the FDA Document Center. Unfortunately, the FDA Document Center cannot accept system files. The problem was that I couldn’t see the files, because they are hidden.

How can you delete a file you can’t see?

I had a software problem, and the process used to fix software problems is called debugging.

Debugging Windows Software Updates

There is a specific position that you should be in when you are trying to debug a software problem. First, you need to be sitting down and hunched over your computer. Second you need to rest your forehead in your hand, sigh heavily and maybe even moan softly from time to time. Personally I prefer to curse the genius programmers at Microsoft and repeat my mantra of “I can’t believe this. It’s ridiculous.” You really know you are concentrating properly if the vein in your forehead is throbbing so much that other people can see it throbbing through your hand.

The most valuable tool for debugging software problems with Windows is Windows Help. It’s an on-line manual that has the answers to every conceivable question you can ask about Windows. The only time it’s really failed to be helpful is when I’m trying to connect to the internet. The “on-line” nature of Windows Help limits its usefulness in solving problems with internet connections for some reason.

Finding eCopy Hidden System Files

I typed into Windows Help, “Show hidden system files.” After a 10 minutes of reading I learned that the default setting for Windows Explorer is to hide system files, and bad things can happen if you unhide those files. I also learned that you can change the default setting by entering the Windows Control Panel, and then clicking on “Appearance and Personalization.” Finally, you click on “File Explorer Options,” click on “View” and then scroll through about 50 possible configuration options until you see the setting for “Hide Protected Operating System Files.” Then you deselect this option–despite the recommendation to keep these files hidden.

Finding the Control Panel

Next I typed into Windows Help, “How to find Windows Control Panel.” Of course there are about 20 different ways to reach the Windows Control Panel, but you only need one. Then I followed the instructions from Windows Help and finally I could see the hidden system folder, but I couldn’t delete it.

Next I tried formatting the USB drive. That worked, until I pulled the USB drive out and inserted it again. Windows has a cool new feature that automatically creates a hidden system folder on your USB drive–even if you don’t want one.

Disable Removable Drive Indexing

Windows Help again to the rescue. I learned that I needed to disable the removable drive indexing feature. In order to do that I needed to use Group Policy Editor, which I didn’t have. Windows Help told me that I could use the Windows Registry Editor or “regedit” program instead if I was unfortunate enough to be using something other than Windows XP. Next Windows Help instructed me to open a folder called Windows Search. Windows Search was a folder found 7-levels deep in the registry of the computer, but it seemed to be missing from my computer. Again, Windows Help instructed me on how to create a Windows Search Folder and add a file called “DisableRemovableDriveIndexing”. Then I only needed to change the settings from a “0” to a “1” and reboot my computer.

Finally, 2 hours later my USB drive no longer had eCopy hidden system files and my computer would no longer create one automatically–until the next Windows update, which occurred a week later. Since I originally posted this article, there have been several Windows 10 updates, and each one has caused problems similar to the eCopy hidden system files. If you prepare your own FDA eCopy submission, please subscribe to my free FDA eCopy webinar updates to keep up with the latest Windows 10 “features” and how the changes will effect your eCopy preparations.

Other Resources

Last week I recorded a live webinar on “510k Lessons Learned.” If you are interested in specific guidance related to eCopy hidden system files, or eCopy submission in general, you can also review the following FDA guidance documents:

  • eCopy Guidance – FDA Guidance document revised 12/3/2015; eCopy Program for Medical Device Submissions
  • eCopies Validation Module (a voluntary tool that verifies the format of an eCopy you have already developed on your local drive)

Posted in: 510(k)

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