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Color change is only device modification. Is a new 510k required?

This article explains the process for determining if a color change and other material changes require a new 510k prior to implementing the change.

color change Color change is only device modification. Is a new 510k required?

I recently taught a frequently asked questions (FAQs) webinar where I asked attendees to provide questions in advance of the webinar and I answered the questions during the webinar. One of the attendees asked how to know if a new 510k is required if the only modification to a device is a color change.

New FDA guidance for device modifications

On August 8, 2016 the FDA released a new draft guidance document for device manufacturers regarding device modifications and when a new 510k is required. The current final guidance is titled “Deciding when to submit a 510(k) for a change to an existing device,” and that guidance is dated January 10, 1997. A draft guidance document on this topic was released in several years ago, but that draft guidance was withdrawn in response to feedback from industry. The new draft guidance document includes modified decision trees to help manufacturers decide which types of changes will require a new submission, but there are also examples provided in Appendix A. The most helpful part of the guidance, however, is Appendix B. Appendix B explains how to document changes properly—regardless of whether a change requires a submission or not.

Decision Trees from the Guidance

There are five decision trees or flow charts provided in the new draft guidance. The purpose of each decision tree is identified below:

  • Main flow chart
  • Decision Tree A = labeling changes
  • Decision Tree B = technology, engineering and performance changes
  • Decision Tree C = material changes
  • Decision Tree D = IVD product changes

How to apply Decision Tree C to a color change

Typically adding a colorant, or changing a colorant, does not negatively impact strength of a device but this is the first cautionary statement made at the beginning of the section for material changes. Therefore, if your device has an performance testing requirements that involve a component that is involved in a proposed color change, then you need to repeat the performance testing to verify that the strength has not been negatively impacted by the color change. Sometimes large concentrations of colorant result in weakening of plastics. Therefore, repeating some of the performance testing or providing data that supports the need for no further testing is expected. In the decision tree this is addressed by question C5, “Could the change affect performance specifications?” If no, then you document the change but a new 510k is not required. If yes, then you refer to decision tree question B5.

The next concern addressed by Decision Tree C is the biocompatibility of your modified device. If the material change of the device or device component comes into direct contact with the body, blood or tissues then biocompatibility risks must be assessed. If the change does create new or increased issues related to biocompatibility then question C4.1 asks, “Has the manufacturer used the same material in a similar legally marketed device?” If the changed material has not been used previously for a similar application, then a new 510k is required—typically a Special 510k if only the material is changed and only biocompatibility needs to be assessed by the FDA.

Reference to FDA biocompatibility guidance

Within the guidance document, the FDA explains that you may want to refer to “Use of International Standard ISO 10993-1, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,’” when you are answering question C4. This new final guidance was released on June 16, 2016 and the Office of Device Evaluation (ODE) appears to be focusing much more closely on biocompatibility since this new guidance released.

Examples of material changes from FDA guidance

There are six examples of material changes presented in the new draft guidance:

  1. Slight change in polymer composition for a catheter = letter to file
  2. Change in polymer for a catheter
    1. Change in a polymer for a catheter to a polymer already used by another manufacturer for a 510k cleared device with the same indications = new 510k submission
    2. Change in a polymer for a catheter to a polymer already used by your company for another 510k cleared catheter of the same type and duration of contact = letter to file
    3. Change in a polymer for a catheter to a polymer already used by your company for another 510k cleared catheter of the same type but shorter duration of contact = new 510k submission
    4. Change in a polymer for a catheter to a polymer already used by your company for another 510k cleared catheter of the same type but longer duration of contact = letter to file
  3. Change in manufacturing method of catheter tubing (i.e., molding to extrusion) = new 510k submission
  4. Change in material for a catheter
    1. New polymer is already used by your company for another 510k cleared catheter of the same type and same duration, but the sterilization method changes (i.e., gamma to EO) = new 510k submission
    2. New polymer is already used by your company for another 510k cleared catheter of the same type, duration, method of manufacturing (i.e., molding) and method of sterilization (i.e., EO) = letter to file
    3. New polymer is already used by your company for another 510k cleared catheter of the same type, duration, method of manufacturing and sterilization, but the performance specifications are slightly different = letter to file (depends upon impact of difference)
  5. Change in dental implant from untreated surface to acid-etched = new 510k submission (may also be considered a design change)
  6. Implantable device is marked temporarily with tape proven not to leave a residue = letter to file

Do you have other questions about biocompatibility?

On Thursday, December 1 @ 11:00am EST I will be hosting a new live webinar on the topic of biocompatibility. The webinar will address both requirements for 510k submissions and for CE Marking technical files. If you are interested in registering for that webinar, please click on the following link:

Click Here for Biocompatibility Webinar 300x64 Color change is only device modification. Is a new 510k required?

Do you have a question about your 510k submission?

If you have a question related to your 510k submission, you can submit your question to me and download the webinar recording for free by clicking on the following link:

Click Here for 510k FAQs Webinar 300x64 Color change is only device modification. Is a new 510k required?

 

I will respond your question by email, but most questions make great future blog topics—like this one.

You might also be interested in our 510k course series:

Click Here for 510k Course 300x64 Color change is only device modification. Is a new 510k required?

You gain unlimited access to 24 webinars related to 510k submission.

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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.

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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.

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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!

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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.

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Implementing Procedures for CAPA, NCMR & Receiving Inspection

The article shares lessons learned from implementing procedures for a new ISO 13485 quality system. This is the second in a series. The first month of procedure implementation was covered in a previous article titled, “How to implement a new ISO 13485 quality system plan in 2016.”

Implementing Procedures Implementing Procedures for CAPA, NCMR & Receiving Inspection

Typically, I recommend implementing a new ISO 13485 quality system over a 6-month period, but recently I a few clients have requested my assistance with implementing a quality management system within 4 months. In November I wrote an article about implementing a new ISO 13485 quality system. That article described implementing procedures for the first month. Specifically, the implementation of the following procedures was covered:

  1. SYS-027, Purchasing
  2. SYS-001, Document Control
  3. SYS-002, Record & Data Control
  4. SYS-004, Training & Competency
  5. SYS-011, Supplier Quality Management
  6. SYS-008, Product Development
  7. SYS-010, Risk Management
  8. SYS-006, Change Control

These 8 procedures are typically needed first. This article covers implementation of the next set of procedures. During this month, I recommend conducting company-wide quality management system training for the ISO 13485 and 21 CFR 820.

Implementing Receiving Inspection Procedures

During the first month procedures for purchasing components and services are implemented. As these products are shipped and received by your company, you need to create records of incoming inspection. It is not sufficient to merely have a log for receiving inspection. You need records of the results of inspection. You may outsource the inspection activities, but receiving personnel must review the records of inspection for accuracy and completeness prior to moving product to your storage warehouse or production areas. Even if inspection is 100% outsourced, it is still recommended to periodically verify the inspection results independently on a sampling basis. This is should be a risk-based sampling that takes into account the importance of the item being inspected and the existence of in-process and final inspection activities that will identify potential nonconformities.

The most difficult part of this process typically is identifying inspection procedures and calibrated devices for inspection. Your company must find a balance between inspections performed by suppliers, incoming inspection, in-process inspection and final inspection. Each of these process controls requires time and resources, but implementation should be risk based and take into account the effectiveness of each 

inspection process–as determined by process validation. Sample sizes for inspection should also be risk-based.

Implementing Procedures for Identification and Traceability

The lot or serial number of components must be identified throughout product realization–including incoming inspection, storage, production, final inspection and shipping. In addition to identifying what things are, you must also identify the status of each item throughout the product realization process. For example:

  • Is product to be inspected or already inspected?
  • After inspection is product accepted or rejected?
  • Which production processes have been completed?
  • Is product released for final shipment?

The procedure for identification and traceability should be implemented immediately after the purchasing process, implemented during 1st month, because traceability requirements should be communicated to suppliers as part of supplier quality agreements and as part of each purchase order.

Initially when this process is implemented there is a tendency to complete forms for every step of the process and to distribute copies of the forms to communicate status. Completing forms and copying paperwork requires labor and adds no value. Therefore, learn manufacturing methods and visual indicators such as color coding are recommended as best practices for identifying product and its status.

Implementing CAPA Procedures

When product is identified as nonconforming, corrective actions need to be implemented to prevent recurrence. Procedures need to include the requirement for planning corrective actions, containing product that is nonconforming, correcting nonconformities and implementing actions to prevent any future nonconformities. These procedures also need to address negative trends to prevent nonconformities before product is out of specification (i.e., preventive actions). Procedures also need to provide guidelines for how to verify effectiveness of corrective and preventive actions. Initially the actions implemented will be specific to purchased product that is received and rejected. However, over time data analysis of process monitoring and internal auditing will identify additional corrective and preventive actions that are needed.

The effectiveness of CAPA processes in general requires three key elements:

  1. A well-designed CAPA form
  2. Proper training on root cause analysis
  3. Performing effectiveness checks

In the CAPA training provided during the second month, the best practices for CAPA form design are covered. The training includes several methods for root causes analysis too. Finally, the training emphasizes using quantitative measurements to verify effectiveness of corrective actions. In fact, it is recommended to identify the quantitative acceptance criteria for an effective corrective action prior to initiating actions in order to ensure that the actions planned are sufficient to prevent recurrence.

Monitoring Your Procedure Implementation Process

As indicated in November’s article, I recommend using quantitative metrics to track progress of procedure implementation. For example:

  1. % of procedures implemented,
  2. duration of document review and approval process, and
  3. % of required training completed.

Implementing Procedures for ISO 13485:2016

If you already have a quality system in place a you are implementing procedures that are modified for ISO 13485:2016 compliance, some of the same lessons learned apply. If you are interested in learning more about the changes required for compliance with the 2016 version of the standard, we recorded two live webinars on March 24, 2016.

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ecopy: Hidden System Files Created by Windows 10 Update

This article explains how to fix a 510k submission ecopy on a USB flash drive–including how to debug problems created by the most recent Microsoft Windows 10 Update.

ecopy replacement for 510k submission 1024x422 ecopy: Hidden System Files Created by Windows 10 Update

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 with System Volume Information Folder

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 can not 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 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.” After another 10 minutes of reading I learned about a secret key stroke that pulls up a secret, black menu (Windows Key + “X” Key). On that menu is the Windows Control Panel. Of course there are about 20 different ways to reach the Windows Control Panel, but this secret key stroke is by far the coolest method.

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 a hidden system file on it and my computer would no longer create one automatically–until the next Windows update, which occurred a week later.

Other Resources

Last week I recorded a live webinar on “510k Lessons Learned.” If you are interested in specific guidance related to ecopy, 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)

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FDA Guidance Documents Released Recently

Article reviews FDA guidance documents released in the past few months including the new Final FDA guidance on biocompatibility released June 16.

ODE Final Guidance Documents FDA Guidance Documents Released Recently

For anyone that is responsible for monitoring new and revised regulatory requirements, the FDA guidance documents are something you probably check at least once every month. If you are not familiar with these FDA resources, here are the links for two of the medical device FDA guidance documents webpages:

New Final FDA Guidance Documents

The last time I reviewed an FDA guidance document was in February for the new guidance document from the FDA related to usability engineering and human factors engineering. There was a new final FDA guidance document released by the office of device evaluation on June 16: “Use of ISO 10993-1“.This biocompatibility guidance was expected for release in December, but the release was delayed.

Use of ISO 10993-1

The new biocompatibility guidance that was published last month provides specific guidance about the application of certain tests required for demonstrating biocompatibility. For example, test article preparation and risk assessments for the applicability of specific tests is addressed. A revised test matrix is included in the guidance document. Special considerations are provided for each of the following biocompatiblity tests:

  • cytotoxicity,
  • sensitization,
  • hemocompatibility,
  • pyrogenicity,
  • implantation,
  • genotoxicity,
  • carcinogenicity,
  • reproductive and developmental toxicity, and
  • degradation assessments

New Final Rule for Symbology

In addition to FDA guidance documents, the FDA also released a final rule on symbology that will modify 21 CFR Parts 600, 801 and 809. The FDA is finally changing its position on acceptance of harmonized symbols in lieu of English text. The FDA is accepting ISO 15223-1 as a recognized standard and allowing manufacturers to use the symbols instead of English text in order to facilitate global harmonization of labeling. The FDA is only allowing the use of Rx-Only as to indicate that a product is prescription only. The guidance even defines the acceptable process for creating new product-specific pictograms. The effective date of the new final rule will be September 13, 2016. 

New Draft FDA Guidance Documents

In addition to final FDA guidance documents, there have been several new draft guidance documents that were released recently:

  1. List of Highest Priority Devices for Human Factors Review
  2. Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”)
  3. Characterization of UHMWPE for Orthopedic Devices
  4. Technical Considerations for Devices for Additive Manufacturing

The second two FDA guidance documents focus on materials that are important for orthopedic manufacturers, because UHMWPE is used as a wear surface for join implants and many of the implants and instruments are now being manufactured using additive manufacturing instead of forging, casting or milling bar stock.

How to keep up on FDA Regulation Changes

If you are interested in keeping up on new and revised regulations from the FDA, I wrote a blog explaining 4 ways to to identify new and updated FDA regulations. The blog identifies FDA webpages for the following 4 types of updates:

  1. Guidance Documents
  2. Recognized Consensus Standards
  3. Device Classifications
  4. Total Product Lifecycle (TPLC) Database

The ISO 15223-1 standard for medical device symbols has been released for several years, but it was not recognized by the FDA until June 14, 2016. The recognition of the Standard is part of the implementation process for the new final rule regarding the use of symbology for medical device labeling. The timing of this new final rule coincides with implementation of UDI labeling requirements for Class II devices. In addition, the new European Medical Device Regulations now specify labeling requirements for the primary sterile packaging as part of Essential Requirement (ER) 19.2:

  • (a) an indication permitting the sterile packaging to be recognized as such,
  • (b) a declaration that the device is in a sterile condition,
  • (c) the method of sterilization,
  • (d) the name and address  of the manufacturer,
  • (e) a description of the device,
  • (f) if the device is intended for clinical investigations, the words: ‘exclusively for clinical investigations’,
  • (g) if the device is custom-made, the words ‘custom-made device’,
  • (h) the month and year of manufacture,
  • (i) an indication of the time limit for using or implanting the device safely,
  • (j) an instruction to check the Instructions For Use for what to do if the sterile packaging is damaged etc.

These new requirements will require many manufacturers to redesign labeling for sterile packaging and the ability to use symbology will assist in creating globally harmonized labeling.

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FDA 483 Inspection Observations Pareto Chart for FY 2015 Data

This article presents a Pareto Analysis of FDA 483 inspection observations from FY 2015 and compares the trends observed with a similar Pareto analysis that was performed a couple of years ago on FY 2013 data.

FY 2015 Pareto Analysis of FDA 483s FDA 483 Inspection Observations Pareto Chart for FY 2015 Data

Method of Data Analysis for FDA 483 Inspection Observations

The FDA posts Excel spreadsheets on it’s website in order to download data for FDA 483 Inspection Observations. These spreadsheets include inspection results for all the divisions of the FDA. In order to perform a data analysis for FY 2015 results, I deleted the sheets that were not specific to medical device manufacturer inspections (i.e., only used data from CDRH). I sorted the data by the regulation that was referenced. For example, all the sub-clauses for 21 CFR 803 were combined into one category for the Pareto analysis. The combined categories were then sorted from the most frequent 483 inspection observation to the least frequent 483 inspection observation. The data was then added to the graph that I produced in February 2014 using FY 2013 results as a second data set. The resulting graph is shown above.

Comparison of FDA 483 Inspection Observations between FY 2013 and FY 2015

For MDR Compliance (i.e., 21 CFR 803), there was a slight increase in the number of 483 observations issued from FY 2013 to FY 2015. However, the difference was only a 1% increase from 6.2% to 7.2% of the total number of 483s issued. There was an even smaller increase in the number of findings related to purchasing controls (i.e., 5.6% increased to 6.1%). I noticed a slight drop in the number of findings related to design controls, CAPA and complaint handling. However, the overall trend for FY 2013 and FY 2015 is essentially the same.

There are two other categories where an increase was observed: 1) process validation increased by 0.7% from 4.8% to 5.5%; and 2) control of nonconforming product increased 0.8% from 4.3% to 5.1%. These areas are important. Control of nonconforming product is one of the major sources of CAPAs and often results in design changes. Therefore, FDA inspectors are reviewing your data for nonconforming product during inspections  in order to help them identify potential CAPAs and design changes that may have been made. The typical sequence is: 1) nonconformity, 2) investigate nonconformity as part of a CAPA, and 3) initiate a design change as a corrective action.

Process validation is a completely different area that is separate from CAPA, complaint handling and MDRs. However, inadequate process validation is a common root cause for nonconformities. Therefore, inspectors often follow an audit trail from a nonconforming product record back to a process change that was implemented but inadequately validated. Therefore, an increased focus on nonconformities may be the reason for an increase in FDA 483 inspection observations related to process validation.

So what’s the big deal?

This proves that the FDA inspectors continue to be predictable. The “playbook” for FDA inspections is the QSIT Manual. It hasn’t changed since 1996. Yet, companies continue to be shocked and amazed by FDA inspectors.

Additional Resources

If you want to learn how to prepare for FDA inspections, I recorded a webinar you can download (FREE). I recorded the webinar in May of 2014, but it’s been a couple of years and I’ve learned a few new tricks. Therefore, I’m going to re-record the webinar and update it for lessons learned. I’ll even share a few tools and approaches to avoid findings and reduce the risk of warning letters. I’m even evaluating a new application that is designed for teams to have private chats and file sharing during an inspection. Stay tuned to my webinars page and I’ll post that webinar soon. Maybe I’ll record something from Germany next month.

Until then, I am working on an webinar specific to medical device reporting. Many companies have still not updated their MDR procedures to reflect the eMDR process using electronic submissions gateways. Therefore, I’m releasing an updated procedure for MDRs and I am offering a webinar bundle to train people how to comply with 21 CFR 803 and the procedure. You might also be interested in my previous webinar specific to control of nonconforming product.

Posted in: FDA

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Finally, New European Medical Device Regulations are Confirmed!

This article announces confirmation of the New European Medical Device Regulations by negotiators of the Dutch presidency of the Council and EU Parliament.

Confirmed Finally, New European Medical Device Regulations are Confirmed!

Announcement of New European Medical Device Regulations

Yesterday, May 25, the European Parliament and the Dutch presidency of the Council reached an agreement and it was announced in press release.

The agreement is subject to confirmation by permanent members of the Council and Parliament’s Envi Committee. The new regulations include the following substantial changes:

  • A scrutiny process for high risk (i.e., Class IIb implants and Class III) products
  • Eudamed database will be expanded to provide public access to information about Notified Bodies, Economic Operators (i.e. – manufacturers, importers, distributors, authorized representatives, etc.) and comprehensive product information
  • Eudamed database will become publicly accessible for searching market surveillance and vigilance data (similar to the FDA’s MAUDE database)
  • Implementation of a Unique Device Identifier (UDI) requirement in Europe.

The Eudamed database will be an invaluable global resource for manufacturers, physician and patients.

Next Steps for New European Medical Device Regulations

The next step in the process of approving the new regulations is an invitation of the Council’s Permanent Representatives Committee and the Parliament’s ENVI Committee to endorse the agreement. The regulations will finally be adopted by the Council and the Parliament after Committee approvals and we can expect implementation of the regulations this fall. The new regulations will have a three year transition after publication for medical devices and a five year  transition for in vitro diagnostic medical devices.

MedTech Summit June 13-17

On June 13 I will be in Brussels at the MedTech Summit hosted by Informa Life Science. There will be 300+ attendees with a fantastic assembly of industry experts representing the Competent Authorities, Notified Bodies and manufacturers. This meeting provides a unique opportunity to learn and discuss the details of the New European Medical Device Regulations and the challenges we will all face in the preparation for the transition to the New European Medical Device Regulations. I will have the pleasure of speaking about risk management and its integration with device design, post-market surveillance and labeling. I will also be Chairperson for the Labeling Stream in June 16.

Please stay tuned to my blog feed. I will be posting related blogs over the next month.

Register for the MedTech Summit

Click on the blue text above to register or you can also call Informa Life Sciences at: +44 (0) 20 7017 7481 or registrations@informa-ls.com.

New Live Webinar on MDRs June 9, 2016

I’m releasing an updated procedure for MDRs and I am offering webinar bundle to train people how to comply with 21 CFR 803 and the procedure. The webinar is scheduled for June 9. I’m even offering two times to accommodate companies in Europe as well as the USA.

Here’s a link for the webinars page.

Posted in: CE Marking

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