Chart: More 510(k) Reform Fears: Condition of Clearance Studies, GMPs?
This article was originally published in The Gray Sheet
Executive Summary
FDA is weighing other changes to the 510(k) program, as well, such as requiring "condition of clearance" studies for 510(k) devices, a common practice for PMA approvals, or incorporating information from manufacturing inspections into 510(k) reviews.
You may also be interested in...
Device Stakeholders Debate Whether FDA Can, Or Should, Revoke 510(k)s
FDA should have no reason to rescind 510(k) substantial equivalence decisions for marketed devices except in extreme cases of fraud, device industry lobbyists said in recent comments to FDA
FDA May Impose More "522" Studies As Post-Approval Enforcement Tool
FDA says it will more frequently use its authority to mandate so-called Section 522 post-market studies when companies fail to meet their original post-approval study requirements - and this time, the idea might actually stick
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.