FDA's first question confounded several different questions: 1) whether to publish a list of devices for the purpose of encouraging "modernization," 2) whether the age of the predicate was an appropriate criteria for inclusion in the list, and 3) whether 10 years was an appropriate cut-off for the age of the predicate. As a result, answers were often also garbled, making it difficult to determine with certainty which question(s) the commenter intended to address.
To summarize comments on the usefulness of publishing a list of devices for the purpose of encouraging the use of more modern predicates, I identified 20 responses that I thought had addressed this narrow question, regardless of which criteria might be used to determine inclusion on the list. Of these 20, 16 said No.
Three patient groups and one inventor supported publication of a list, but it was not clear they were aware that information on the "history of predicates" was already publicly available in FDA's 510(k) database. The comments of all three patient groups clearly had a common authorship; two groups submitted identical comments; the third group submitted comments that might be called, ironically, "substantially equivalent" to those submitted by the other two groups.
The rest of the commenters were trade associations, device companies, or individual industry professionals. All were opposed the publication of this type of list.
Multiple commenters expressed doubt that such a list would serve any purpose, including to encourage "modernization." There was a strong consensus that publication of this type of list was likely to have a number of undesirable consequences, including:
- Perception by "the public" that the listed devices as less safe and effective than other 510(k) devices.
- Confusion among patients and physicians regarding the meaning of the list.
- Refusal of reimbursement for the listed devices.
- Refusal of insurance for liability related to use of the listed devices.
- Removal of the listed devices from the market.
- Damage to the device manufacturer's reputation, earnings, and future potential.
- Damage to innovation of the listed devices and their predicates, because they would be perceived as "bad" predicates.
- Perception that FDA is allowing devices that are not adequately safe or effective to remain on the market.
- Damage to public perception of the substantial equivalence framework as adequate to assure device safety and effectiveness.
- For prescription devices, a perception that FDA is attempting to regulate the practice of medicine.
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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------------------------------