Survival of Third-Party Review Threatened by Recent Letter

The FDA’s third-party review program took another hit recently when the agency sent a letter to some devicemakers saying they can no longer use independent reviewers for their 510(k)s. The move by the FDA could prove fatal for the program that has struggled to catch on with devicemakers, although CDRH Director Jeffrey Shuren has promised to keep third-party review in place until at least 2011 when the Institute of Medicine is expected to complete its external review of the 510(k) process.
Devices & Diagnostics Letter