The FDA third-party review program for 510(k) devices, known as 3P510k, may be revived if recent signals from the agency and Capitol Hill are any indication. While we at Enzyme do not see the 3P510k program as a universally faster path to market for all 510(k) filings, recent developments suggest that this program could once...

By Shawn M. Schmitt Communications Specialist, Enzyme When the US Food and Drug Administration (FDA) begins auditing MedTech companies under the new Quality Management System Regulation (QMSR) in 2026, the agency’s facility investigators will be looking for more than simply ticking off compliance checkboxes. They will expect companies to demonstrate a culture of quality, where...