RAPS

FDA Ends Voluntary Audit Pilot Ahead of 'Fully Operational' MDSAP

The US Food and Drug Administration (FDA) says it is discontinuing one of its audit-sharing pilots ahead of the launch of a "fully operational" Medical Device Single Audit Program (MDSAP) in 2017. FDA ...
JD Supra

FDA medical device inspections in 2025: What we're seeing, what we expected, and why you need the right expertise now

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...
JD Supra

The QMSR Goes Live and FDA Implements a New Medical Device Inspection Technique

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice regulations with the international ISO 13485 standard, Medical ...
MD&M East

Medical Device Companies Must Navigate Historic FDA Rule Change

On Monday, February 2, a new final rule from FDA changing QMS requirements for medical devices went into effect. Manufacturers have had over two years to comply with the new rule, which is now full ...
RAPS

New FDA Notice Provides Details on IMDRF's Medical Device Single Audit Program

With the demise of the Global Harmonization Task Force-a regulatory harmonization body focused on medical devices-in 2012, much attention has been paid to its successor, the regulators-only ...