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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. Read More
The FDA hit Grind Guard Technologies with a Form 483 for failing to review all complaints, faulty procedures for suppliers and quality audit deficiencies. Read More
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. Read More
The European Union’s Medical Device Coordination Group released a trio of guidances that clarify devicemakers’ responsibilities for implementing unique device identification systems under the EU’s new Medical Device Regulations. Read More
Health Canada is sticking to its compliance deadline of Jan. 1, 2019, for devicemakers selling products in Canada to transition to the Medical Device Single Audit Program, but it is making adjustments to help manufacturers comply. Read More
The FDA flagged three U.S. facilities and two in Europe for a variety of deficiencies including CAPA failures and investigations of nonconforming products. Read More
Nearly 80 percent of the 1.6 million medical devices registered in the FDA’s Global Unique Identification Database are Class II medical devices and nearly half are implantable devices, the FDA reported. Read More