By my count, FDA's last two questions elicited responses from 27 different commenters. Both questions asked about actions FDA might take. Most of the commenters offered one or more suggestions, but there didn't seem to be much meaningful difference between the suggestions offered in response to one question or the other:
- The first of FDA's last two questions was limited to actions it might take "to promote the development and marketing of safer, more effective 510(k) devices." Not all commenters appeared to understand the development and marketing of 510(k) devices well enough to know if the actions they suggested fell within this scope. Others seemed not to feel the need to limit their suggestions to the scope of FDA's question.
- FDA's last question was limited to actions that would require "new authority." It seemed unlikely that many of the commenters were in a position to know whether their suggestions would require "new authority."
Some of the suggestions were actions that FDA could take to make it easier to develop 510(k) devices and/or get clearance, rather than safer, more effective 510(k) devices. A few suggestions were actions that would serve some other purpose. Suggestions that I thought were responsive to FDA's question included:
- Add the age of the predicate device to the RTA checklist and require justification of the use of an older predicate.
- Advise manufacturers to use the latest relevant predicate available
- Consider sunsetting certain older predicates.
- Allow manufacturers, particularly in low-risk, well-defined industries to justify the use of older predicates.
- Provide more transparency on safety and performance information for predicates, as well as a fast, easily accessible way to check predicates.
- Address the limited availability of predicate device information.
- Develop a way to "reward" devices that clearly make an effort to advance safety and/or effectiveness.
- Issue special guidances to address specific concerns about a device or device type.
- Require sufficient testing before approval.
- Update the current classification system to keep pace with the risk/benefits of today's technologies and materials.
- Make each intended use statement condition specific, rather than clearing devices for broad use throughout the body.
A few suggestions seemed intended to "modernize" 510(k) devices. Since the proposal was based on the assumption that "more modern" meant "safer and more effective," I decided these suggestions were also responsive, if somewhat indirectly.
- Update the performance testing criteria for the latest technology.
- Encourage design development processes during the early phase of development that evaluate if a technology is within the state of the art, and which provide ongoing assessment throughout the product lifecycle.
- For products that could benefit from improved technology or performance standards, reclassify the procode, set performance standards, and let manufacturers respond with new submissions.
In contrast to those who suggested actions, those who said no further actions were needed had different perspectives, depending on which of the two questions they were answering:
- Five commenters said no to alternative actions to promote the development and marketing of safer, more effective 510(k) devices. One thought action should only be taken when concerns existed for a particular device or device type. The other four said that the 510(k) should simply be scrapped. Several referred to the Institute of Medicine's 2011 report.
- Eleven commenters said no to "certain actions" that might require new authority, because they thought FDA had sufficient, if not more than sufficient, authority already. One patient added that the problem with device safety was FDA's failure to enforce the authorities it already has.
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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------------------------------