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Informational FDA Proposal to "Modernize" the 510(k) - 2019

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Watchcat

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The period for comments on FDA's lame proposal to "modernize" its 510(k) process closed in May:

Regulations.gov

A total of 55 comments represented a diverse range of stakeholders, including 6 device companies (large and small), 1 software company, 6 trade associations, 1 third-party payor, 19 individual industry professionals, 14 individual patients, 5 patient groups, and 1 "think tank." In spite of this diversity in perspectives, the comments reached a strong consensus on FDA's proposal:

NO.

I recently summarized the comments across 7 posts on LinkedIn. Eventually I will consolidate these into a single document, which I will post here. In the meantime, I'm attaching my own comments. I'm also attaching the Conclusions and Recommendations from the 2011 IOM Report, which several commenters, including me, referred to in their comments.
 

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