Temple review followup audit
This article was originally published in The Gray Sheet
Executive Summary
FDA device center completes sample selection of approximately 30 premarket approval and 510(k) submissions for internal review as a followup to an audit conducted by the Committee for Clinical Review (the "Temple Group") ("The Gray Sheet" June 21, In Brief). The agency is conducting the review to determine whether application deficiencies are more widespread than those uncovered by the Temple Group's initial report. The sample is comprised mostly of randomly selected device applications, but also includes several applications for currently marketed devices for which the center has safety concerns....