The Medical Imaging & Technology Alliance is calling on the FDA to establish a framework that distinguishes between servicing and remanufacturing activities for medical imaging devices. Source: The GMP Letter

The FDA hit six facilities for various failures including inadequate validations, CAPAs, written procedures and supplier evaluations. Source: The GMP Letter

Australia’s Therapeutic Goods Administration reached the end of its three-year transition period to the 2016 version of ISO 13485 and devicemakers using the updated standard to show Quality Management System…

The FDA issued a proposed rule aimed at modernizing mammography quality standards and better positioning the agency to act when violations are found. Source: The GMP Letter

Two breast implant manufacturers were served with warning letters after the FDA found they failed to comply with post-approval study requirements. Source: The GMP Letter

The FDA is considering a total product lifecycle monitoring approach to emerging artificial intelligence devices, the agency said in a proposed rulemaking issued April 2. Source: The GMP Letter

FDA Commissioner Scott Gottlieb and CDER director Jeff Shuren announced plans to promote device innovation and safety in 2019 using new premarket pathways as well as new safety and performance…

The European Medicines Agency issued final guidance on new rules for certain in vitro diagnostics and medical devices. Source: The GMP Letter

FDA Commissioner Scott Gottlieb announced that the agency is ramping up its efforts to improve recall notifications and public warnings. Source: The GMP Letter

The FDA is planning to exempt certain unclassified devices from premarket notification requirements, according to an updated guidance from the agency. Source: The GMP Letter