It was very difficult to "count" anything in these responses. I'm not only certain that others would get different counts than I did, but that I would get different counts myself, if I started over and repeated the process.
In this case, I don't think it matters much. There was such a strong consensus on the responses to FDA's main questions, one or two overlooked or miscounted responses wouldn't make a dent. The diversity was in the details. And there were plenty of them, lol. Regardless, I hope my summary will give those who don't have time to read all 55 responses a good idea of the overall response to FDA's proposal. This is the first time I've been that ambitious; usually I just click on a selected sample, to get a general idea of how different constituents are responding.
I found many of the responses very educational, a rare opportunity to get the prospective of numerous players on a topic of interest. Some raised points I hadn't considered; others provided different perspectives on the same points I had raised.
I will say yet again how impressed I was with the time and effort that many organizations and individuals put into their comments. Some, almost too much, lol. The companies and trade associations sometimes seemed to confuse regulations.gov with a lecturn, writing fairly lengthy treatises on the 510(k) process. They also often responded at some length and then finished with their answers to FDA's questions, which by then were often redundant.
If you would like to do some directed reading, you might want to peruse some of these comments:
AdvaMed and MDMA - Both did a very capable job, IMO, and their comments are presumably based on a consensus among multiple device companies.
I thought the Consumer Healthcare Products Association (CHPA) did a great job at describing the value of older predicates.
BCBSA – This is the first time I've read a payor's comments on a regulatory matter. I thought it did a capable job as well.
If you like evidence, read Jeff Shapiro. If you like standards, read MITA. If you like the "real world," try the BRIDGE Coalition.
Several individual companies did a capable job of responding as well, but, without going back to do a point-by-point comparison, I don't think they raised any significant issues that you won't find covered in comments above. An issue addressed by several trade associations and companies was the bad rap that the 510(k) has taken lately, and suggested ways to improve public perception. Not that FDA asked.
Jean Bigoney previously posted her comments to the Forum. They reflect a wealth of experience with the predicate selection process, and are well worth a read if you missed them the first time.
Easily my favorite comments were those made by Samuel Lynch, not only for their content (i.e., he agrees with me, including on some points I didn't include in my own comments), but also because of the diversity of experience they reflected.
Don't bother to read any patient comments. Some are not bad, but in the end you won't learn anything, except maybe why patient activists are so seldom taken seriously. Don't bother with the comments by National Center for Health Research, either.
(No, not done yet. I will do one more post on this topic. It will describe my personal take on FDA's proposal and the comments it inspired.)
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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------------------------------