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." Not all commenters addressed all of FDA's questions; some didn't address any.
Only 6 of the commenters who chose to comment anonymously. Of these, 4 included information in their comments that allowed me to classify them with reasonable confidence into one of the groups listed above. I classified 2 anonymous posters as unknown, but it seemed clear that they were either industry professionals or reasonably knowledgeable and undramatic patients.
The software company took the opportunity to pitch their benchmarking product. I included their input as a single suggestion to use benchmarking. The other companies provided comments that were often extensive, and mostly on point.
The majority of individuals who commented on the proposal were medical device professionals commenting on their own, instead of on behalf of their company. The majority of these commenters were RA professionals. Individual commenters also represented the personal perspectives of healthcare industry professionals and an attorney.
Many of the patients did not address FDA's proposal or its questions about the proposal, but instead told their stories of being injured by devices, provided detailed information about adverse events reported for certain types of devices, and/or complained about the 510(k), FDA, device companies etc. If a patient made a statement that was responsive to a question, whether they intended to answer that question or not, I included that response. No comments were included for 10 patients, because they were not responsive to FDA's proposal.
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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------------------------------