The FDA has finalized a list of accessories that can be classified as Class 1 devices. The listing was required under the FDA Reauthorization Act of 2017. Source: The GMP…

The FDA considers first aid and other “convenience” kits a single device for regulatory purposes, the agency said in final guidance. Source: The GMP Letter

The FDA gave sponsors of combination drug/device products another year to get their IT affairs in order before complying with new postmarket safety reporting requirements. Source: The GMP Letter

The FDA issued final guidance recommending what information devicemakers should include in test report summaries, test protocols and complete rest reports for non-clinical bench performance testing for their premarket submissions.…

CDRH Director Jeff Shuren said the center is considering regulatory actions because of ongoing concerns over contaminated duodenoscopes. Source: The GMP Letter

The FDA cited three devicemakers for nonconforming products, documentation failures, inadequate CAPAs and numerous other problems found during agency inspections. Source: The GMP Letter

The FDA issued a draft guidance and proposed order designed to ensure the safe and effective use of surgical staplers and staples for internal use. Source: The GMP Letter

The European Commission released long-awaited guidance on Eudamed (the European Database on Medical Devices) and the device nomenclature system that will be used for the EU’s new medical device and…