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510(k)

US Regulators Plan Overhaul of Third-Party 510(k) Review Program

EMERGO SUMMARY OF KEY POINTS:

  • US FDA is amending its 510(k) third-party review program 3PRO to reduce the need for agency re-reviews of these submissions and market entry delays.
  • As part of the 3PRO overhaul, FDA will adjust its list of eligible devices to focus more on lower-risk, less complex products.
  • By 2021, FDA wants 85% of 3PRO-reviewed 510(k) submissions to go through without the need for agency re-review.

FDA Reveals Some of its 510(k) Reforms

The US Food and Drug Administration (FDA) has rolled out the 510(k) premarket notification process for moderate-risk medical device clearance. The more polarizing aspects of the FDA’s plans, including establishing a new Class IIb device category requiring clinical information to support equivalence determinations as well as requiring postmarket surveillance studies as a condition of clearance for some devices, will not be finalized until after an independent report by the Institute of Medicine is issued later this year.

FDA Proposes Recordkeeping Requirements for Third-party 510(k) Reviewers

The US Food and Drug Administration (FDA) has proposed (Docket No. FDA–2010–N–0447) new rules targeting how third-party premarket notification (510(k)) reviewers appointed by the agency maintain relevant documents and records. Specifically, the FDA has submitted rules regarding the Third Party Review Program established under the Food and Drug Administration Modernization Act of 1997.