Comments on reasons for third-party review pilot's unpopularity sought by FDA in letter to industry.
This article was originally published in The Gray Sheet
Executive Summary
FDA SEEKING COMMENTS ON THIRD-PARTY REVIEW PILOT "LOW UTILIZATION" through a letter on the pilot sent to third parties and device trade groups during the week of Nov. 18. Calling for comments by Dec. 15, the agency asks respondents to discuss "factors that may account for the industry's low utilization of the pilot program to date."