(I am doing RAPS a favor by keeping my personal commentary brief--the closest I get to what some people call "diplomatic." I may comment more pointedly and at more length on LinkedIn and/or my website later, depending on how my time goes.)
1) From the perspectives of the various constituencies were represented by the commenters, it seems to me that this proposal was unarguably a fail. This brings me back to Jeff Shuren's statement that CDRH needed permission to fail at its efforts to modernize the 510(k), which he made over two weeks after the comment period had closed. If he had been referring to this proposal, at that point, clearly it was too late to seek permission and the only option left would have been to seek forgiveness. I wonder if that means the actual fail is yet to come. This seems likely to be the result if the FDA decides to publish the list in spite of all the comments, which I found to be more than persuasive on that point. Time will tell.
2) I was again struck by the extent to which FDA doesn't seem to be walking its talk these days. Like numerous other commenters, I picked up the lack of evidence to support its proposal, although I think I was the only one to point out the disparity with its talk. I completely missed the most glaring example of "all talk/no walk." Fortunately, numerous other commenters did not. FDA talks endlessly about "real world" evidence. Then it proposes to publish a list that is intended to encourage the use of predicates with "modern" technology over the very predicates that are most likely to be solidly supported by decades of clinical experience and "real world" evidence. Ouch.
3) This exercise got me to re-thinking policy. In another life, I worked with a number of different policy experts, in education and healthcare, at the state and federal level. They struck me as knowledgeable in their areas and thoughtful in their policy considerations. I thought policy was pretty cool, and I could have easily gone down that path professionally. Now I'm wondering if I just got lucky in the policy experts I worked with, or if, over time, policy has deteriorated into yet another area that operates largely in ignorance of its subject matter. This proposal seemed to be founded in near total ignorance of how the 510(k) process is used, including how predicates are selected, and what characteristics are important in a good predicate.
4) I come back to the time, thought, and effort that many commenters had so clearly put into their comments, whether they commented on behalf of an organization, a company, or just themselves. For some, it was part of their jobs, but for others, it wasn't. Regardless, people invest time and effort into things that matter to them, for whatever reason. I found the contrast between many of the comments and FDA's proposal, which was based on no evidence, little thought (at least, I hope not), and, IMO, was generally a mediocre document, to be both striking and discouraging. My most enduring take away from this exercise will probably be, sadly, that the only player in the game to whom FDA's regulation of 510(k) devices doesn't seem to matter much is FDA.
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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------------------------------