Third Party Review

Metrics for Third-Party 510(k) Reviews

On January 26, 2018, FDA issued the first performance metrics for third-party reviewers of 510(k).  Going forward, a summary of Third Party Performance Metrics will be posted on a quarterly basis. At this time, there is one Third Party Review Organization with at least 5 completed submissions. A Third Party…

FDA Plans to Eliminate Orphan Designation Backlog

Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to…