I identified 10 commenters as having responded to FDA's question about whether it should consider criteria other than the age of the predicate "to inform our point of reference." I interpreted this phrase to mean "to identify devices for inclusion on a public list." One commenter said no, because they thought that "the current substantial equivalence process is robust." Since the current process doesn't include a list, I gathered this commenter interpreted FDA's somewhat murkily worded question to mean other criteria it should use "to inform a determination of substantial equivalence."
The other 9 commenters suggested a variety of criteria, including:
- Commercial availability and viability
- Type of and changes to technology
- Nature of and changes to intended use
- Scope and rapidity of innovation for that device type
- Conformance to standards, guidelines, specifications
- Demonstrated safety and effectiveness
- Clinical track record
- History of adverse events, recalls, market removals
- Risk class, risk profile, risk analysis, risk to benefit
- Specific concerns about a particular device or device type
Most of those who offered suggestions had shown little to no enthusiasm for a list, and appeared to be offering these suggestions just in case FDA decided to publish one despite everyone's best efforts to persuade it not to.
One patient group suggested a clinical record of at least a 95% survival rate at 10 years from entry to market. Sigh.
------------------------------
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------------------------------