Device Lawyer Is Cautiously Optimistic About Revised Third-Party Reviews

A device industry lawyer expressed guarded confidence in a draft guidance FDA released last month that aims to revamp the agency’s 510(k) third-party review program, where qualified organizations review 510(k) submissions for certain low-risk devices. Rachael Hunt, an associate for Hyman, Phelps & McNamara, writes that the program has a reputation of inefficiency, but the proposed changes -- including higher standards for reviewers, auditing of reviewers, and quarterly, public reports of reviewer performance -- could help make the program more...