Regulatory Open Forum

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  • 1.  510(k) Device Modifications

    Posted 11-Oct-2016 01:03

    After the 2011 draft guidance on 510(k) device modifications was withdrawn, and FDASIA was passed, and FDA released a whole slew of new guidances, what was the end result for 510(k) device modifications?  What are the differences between how 510(k) device modifications are to be handled now, versus how they would have been handled if the 2011 guidance had been finalized instead of withdrawn?

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
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  • 2.  RE: 510(k) Device Modifications

    Posted 11-Oct-2016 05:17

    FDASIA directed FDA to go back to the 1997 guidance. That is the guidance in place today. However, FDA has issued two draft guidance documents. One is a general guidance and the other is specific to software changes.

    They both place heavy reliance on risk management, expecting an ISO 14971:2007 approach.

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    Dan O'Leary
    Swanzey NH
    United States

    Original Message


  • 3.  RE: 510(k) Device Modifications

    Posted 11-Oct-2016 10:17

    The 2011 draft guidance used such a conservative interpretation of "could impact safety and effectiveness" that it would have resulted in thousands more 510(k)s per year. Purely given the numbers over the past few years, I'd say no one has implemented those principles.

    As Dan said, they recently released 2 new guidances in an attempt to "clarify" the 1997 guidance. While these guidances still have some issues (not the least of which is they use only obvious examples and not exmaples highlighting any of the grey areas that actually cause problems for manufacturers), I suspect they reflect FDA's current thinking. They are also a big improvement over the previous draft guidance, particularly in that they leverage risk management approaches and do not say you must submit simply because you conducted some type of DV&V testing. I think at least a few companies are using the principles included in these documents to assess current filing decisions.

    g-

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    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States

    Original Message


  • 4.  RE: 510(k) Device Modifications

    Posted 12-Oct-2016 07:28
    Two things from our vantage point.  We are in the throes of putting out a Client Alert on modifications. One of the biggest things we note is how FDA migrates away from the statute and regulatory terms "major" change to the intended use and "significantly affects" safety and effectiveness.  FDA finds substitute language that lowers the bar all throughout the document.  Read it carefully. We won an appeal this year on whether a change was a major change to the intended use.  We had helped the client do their letter to file (versus 510(k)). FDA review staff all the way up to the Division Director disagreed with us and used their findings to base a Warning Letter  and Public Health Alert on it.  Dr. Maisel and lawyers from the Office of Chief Counsel overturned the Division.  It took them 18 months to issue the decision because of its import to this very debate.  Our Client Alert will discuss this case in more detail.  The issue is that the statute and regulations imply that changes can be made to the intended use as long as they are not major.  In 510(k) negotiations the review staff coerced the company into "stuffing" the intended use statement with language not found in the predicate in order to obtain a clearance and then objected when the company later modified it (with supporting data).  The change was deemed to not be a change to the intended use much less a "major" change.  The client of course had to make sure the labelled change was substantiated (in this case wiith data) for promotional purposes and it was.

    The second thing is to consider the impact of FDAs guidance on recalls vs enhancements. These are to be independent assessments, but in many cases an enhancement probably should not meet the major or significantly affects standard and may not meet the major or significantly affects standard.



    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 5.  RE: 510(k) Device Modifications

    Posted 12-Oct-2016 01:11

    Dan and Ginger, thanks.  I don't normally pay too much attention to what is happening with 510(k)s, but since their recent evolution seems like it might be tied to the emergence of the direct De novo, I have been curious as to what all of that was about.  It sounds like there was, overall, some forward movement on risk management.

    Examples don't seem to be FDA's strong suit.  Someone else recently said that the only thing they didn't like about another guidance was that the examples were not helpful, and I've seen some not-so-enlightening examples myself.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com

    Original Message