Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
CDRH launches “experiential” learning program, and more regulatory updates.
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Hosting Device Reviewers? CDRH Seeks Industry, Clinical Volunteers For Experiential Training
FDA’s device center is inviting manufacturers and clinical institutions to allow reviewers to visit their facilities and observe firsthand how medical devices are designed, developed and used.
FDA Claims Short-Term Success For Pre-Market Device Reforms
With many of its 510(k) and science reforms at least partially implemented, CDRH says it is seeing tangible, positive results. The device center cites a turnaround on multiple measures of review performance following the lows of 2010.
FDA Gives Details On New Reviewer Training Program
FDA is hoping a center-wide training program for all new reviewers, launched this month, will improve the consistency of medical device pre-market reviews.