ARTICLE SUMMARY:
The program allowing device firms to contract with accredited bodies to review 510(k)s has yet to gain real momentum after 24 years. But FDA says its recent efforts to improve the quality of third-party reviews is having an impact and that the framework is an important underpinning of its global harmonization vision. The head of the leading third-party review firm, meanwhile, acknowledges business is slow, but she is committed to expanding the program.
After more than 20 years on the books, the footprint of FDA’s 510(k) Third Party Review Program remains exceedingly small. But the agency insists it is committed to the framework and that recent actions to improve the program are bearing fruit. FDA also says the universe of third-party review organizations (3PROs) and industry’s interest in leveraging them should increase as momentum builds for another priority area within the global regulatory community: a harmonized medical device single-review program.
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For now, though, the third-party review program, which allows companies to contract with an FDA-accredited organization to perform 510(k) review for eligible devices, barely registers. In FY 2020, FDA recorded 85 third-party 510(k) submissions—about 2% of the 510(k) submissions that come directly to FDA each year. (Additional submissions may go to third parties but manufacturers withdraw them before they reach FDA.)
The program has minimal penetration, in particular among larger device companies, says Prithul Bom, CEO of St. Paul, MN-based Regulatory Technology Services LLC, the most active accredited 3PRO. RTS accounts for more than half of the 510(k)s that go through the program each year. The big device companies based in the Minnesota Medical Alley area “are aware of the third-party program, but nobody utilizes it,” Bom tells Market Pathways.
