US Food & Drug Administration

510(k) Third Party Review Update – April 2011

The FDA’s third-party review program has provided little assistance in alleviating CDRH reviewers’ workloads as the submissions are coming in with serious quality issues and requiring more scrutiny than expected.

Historically, submissions reviewed by a third-party reviewer were directed to a branch chief for sign-off.  But lately, the agency has had to scrutinize submissions more closely due to the poor quality of some of the third-party reviews, it told industry representatives during a meeting to negotiate reauthorization of the Medical Device User Fee Modernization Act (MDUFMA).

In fiscal 2010, the FDA found quality issues with 132 out of the 226 submissions reviewed by a third party, and at least four required an additional four review cycles after submission to the FDA due to the deficiencies.

Out of 14 third-party 510(k) submissions that the agency found not substantially equivalent (NSE), only two were correctly identified as NSE by the third-party reviewer.