The FDA recommended factors to consider and precautions to take for premarket submissions of multiple function device products, noting there is no all-encompassing approach for the wide variety of multiple…

Japan’s Pharmaceuticals and Medical Devices Agency raised its registration fees for most medical devices effective April 1. Source: The GMP Letter

The European Union and the UK have yet to finalize an agreement in their Brexit negotiations on how to handle notified bodies. Source: The GMP Letter

The FDA published draft guidance on metered dose and dry powder inhalers highlighting considerations for critical quality attributes. Source: The GMP Letter

The FDA released final guidance that provides policy clarification for ultrasonic diathermy devices as well as information devicemakers should submit in their premarket notification submissions. Source: The GMP Letter

The FDA hit Grind Guard Technologies with a Form 483 for failing to review all complaints, faulty procedures for suppliers and quality audit deficiencies. Source: The GMP Letter

The International Medical Device Regulators Forum released updates on regulatory works in progress in member countries following its March 20-22 IMDRF meeting in Shanghai. Source: The GMP Letter

The FDA issued a warning letter to SynCardia Systems over issues regarding medical device reporting at its Tucson, Arizona facility. Source: The GMP Letter

China’s Food and Drug Administration asked for additional feedback on draft guidance covering its unique device identification system. Source: The GMP Letter

The FDA flagged three U.S. facilities and two in Europe for a variety of deficiencies including CAPA failures and investigations of nonconforming products. Source: The GMP Letter