Healthcare DIVE September 7, 2023
The agency has made recommendations for selecting predicate devices, using clinical data and conducting performance testing for implants.
Dive Brief:
- The U.S. Food and Drug Administration released three draft guidance documents on Wednesday intended to strengthen and modernize the 510(k) program.
- The agency set out its latest thinking on selecting predicate devices, using clinical data and conducting appropriate performance testing for implants.
- The FDA called the recommendations an important step in the Center for Devices and Radiological Health’s work to optimize the clarity, predictability and consistency of the 510(k) program and implement the 2022 Medical Device User Fee Amendments (MDUFA V).
Dive Insight:
As part of MDUFA V, the FDA committed to cutting the total time to decision...
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