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  • 1.  The Regulatory Watchcat's Comments on FDA's Proposal to "Modernize" the 510(k)

    Posted 22-Apr-2019 20:07
    I posted these comments to regulations.gov today.

    This is the last time I will post one of my official rants in the Forum, and I will eventually remove it and the other two Regulatory Watchcat rants from the Forum library, as they are not really a library resource.  I might post a link to future rants, depending on what I'm ranting about.

    I hope my next Regulatory Watchcat post will be something more useful than a rant, but we'll see.  There seems to be an awful lot to rant about lately.  Or maybe I've just been paying closer attention.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
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  • 2.  RE: The Regulatory Watchcat's Comments on FDA's Proposal to "Modernize" the 510(k)

    This message was posted by a user wishing to remain anonymous
    Posted 23-Apr-2019 12:34
    This message was posted by a user wishing to remain anonymous

    ​Your assessment is biased.  Knowledge and technology used to double every decade and now double every year.  Soon the doubling rate will be in days or hours.   A decade will be a long period of time for lots of technological advancements.  Continuous improvement is necessary.  Studies in the 1990s concluded that better technology was being used to make potato chips than medical products and the 21st century GMP initiative was born to move the industry forward.  In a course on food and drug law that I took at Temple University 15 years ago, the instructor then indicated that devices will be more stringently regulated like drugs and biologics.  Device manufacturers should be looking at cost effective methods of applying more control to devices. Maybe Class 2 devices could have a post market clinical study conducted instead of premarket like class 3 and class 1 still require no clinical study.  Some kind of balance to add more control and understanding of devices without dramatically impacting the availability and improvement of devices.   Encouraging manufacturers to use technology that isn't decades old is just the starting point to move the medical device industry forward.
    Original Message


  • 3.  RE: The Regulatory Watchcat's Comments on FDA's Proposal to "Modernize" the 510(k)

    Posted 23-Apr-2019 20:21
    Edited by Julie Omohundro 23-Apr-2019 20:24
    Indeed, all assessments are biased. 

    Since RA is all about assessing...safety, effectiveness, benefits, risks, I think an understanding of bias and how to address it is important for RA professionals.  What source(s) of bias did you identify in my assessment?  How do you think those biases affected my assessment?



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

    Original Message


  • 4.  RE: The Regulatory Watchcat's Comments on FDA's Proposal to "Modernize" the 510(k)

    Posted 24-Apr-2019 17:28
    I tend to believe that FDA's attempts to try to modernize the process of the 510(k) are short-sighted and would add strain to some parts of the industry.

    I work for a fungal IVD company. Most physicians in our field are still prescribing tests using pre-amendment devices. 40+ year old technology still being used and being considered the gold standard sounds a bit ridiculous, but in our small field, I guess that's the speed at which we are modernizing.  We have key opinion leaders in our field that still question the performance of the ELISA format.

    I understand that certain people think more recent predicates mean higher technology and possibly safer, but often in this field, there may not be a predicate in the past 10 years. A blanket regulation that doesn't take these issues into account doesn't make much sense to me.

    If this potential regulation were to make it more difficult or remove the ability to use a predicate older than 10 years, it could cripple niche fields like fungal diagnostics from ever catching up with modern medicine.

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    Nicolas Garrett
    Regulatory Affairs Associate
    Norman OK
    United States
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    Original Message


  • 5.  RE: The Regulatory Watchcat's Comments on FDA's Proposal to "Modernize" the 510(k)

    Posted 24-Apr-2019 22:57
    When I get a chance, I'm going to write up a summary of the comments on regulations.gov, but just skimming through them, it seems that the idea of a 10-year cut-off went over like a lead balloon.  The lack of evidence to support FDA's proposals was also cited in a number of comments, and several also thought FDA had it backwards...that "tried and true" technology was preferable to "improved" and "advanced."

    I will be interested to see what FDA does with this going forward.  I doubt it is going to implement the suggestion to promote older predicates instead of new ones, and I didn't see anyone offering any alternatives that seem feasible for FDA to pursue, given its resource constraints.

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

    Original Message


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