MedTech Dive November 17, 2023
The agency posted a final guidance and draft guidance on medical device shortage reporting requirements, addressing industry concerns.
Dive Brief:
- The Food and Drug Administration has acted on industry calls for clarity about supply disruption reporting requirements for medical devices.
- Draft guidance released by the FDA last year worried medtech industry groups, which warned that uncertainty about the scope of the reporting requirements could burden manufacturers and the agency.
- The FDA has responded by proposing a list of devices that are subject to the rules. Officials set out their thinking on the list in new draft guidance. The FDA also finalized other aspects of the text on device shortage reporting requirements it released for consultation last year.
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