ARTICLE SUMMARY:
FDA wants to upgrade the 510(k) program to better accommodate modern technology. But industry says the program is already plenty flexible, and the agency’s ideas to invite public scrutiny of older predicate devices or even restrict their use are misguided.
FDA can’t get much love for its 510(k) reform proposals of late. Of most recent note, it is difficult to find any group or individual supporting the agency’s idea to help “modernize” the pre-market clearance program by creating a public listing of 510(k)-cleared devices that rely on predicate devices that are more than 10 years old, or any other age-based threshold.
