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. One effect of the Act (via Section 523 of the ensuing Federal Food, Drug and Cosmetic Act) was to direct the FDA to accredit private-sector individuals to review 510(k) submissions for Class I as well as some Class II devices on a voluntary basis. Following approval of a request for accreditation by the regulator, a third party may review a manufacturer’s 510(k) documents; the third party then sends a copy of the 510(k) as well as his or her own review and recommendation documents to the FDA. The FDA’s proposal recommends that third parties maintain records of their 510(k) review documents for a three-year period in order, claims the regulator, to properly maintain the Third Party Review Program and improve efficiencies around reviewing low- and moderate-risk medical devices. According to FDA estimates, as of 2009 there were 10 accredited reviewers participating in the program; about 260 510(k)s were submitted for third-party review that year. The proposal has been submitted to the US Office of Management and Budget for clearance under the Paperwork Reduction Act of 1995; interested parties have until January 27, 2011 to fax or email written comments.