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The FDA issued a draft guidance and proposed order designed to ensure the safe and effective use of surgical staplers and staples for internal use.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…
Australia’s TGA released five new draft guidances that propose changes to the classification of numerous medical devices to align more closely with European Union regulations. Source: The GMP Letter
CDRH warned that more than 100 device manufacturers and hundreds of devices face potential shortages following an EPA order to stop medical equipment sterilizer Sterigenics’ Willbrook, Illinois facility from sterilizing…
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…
The FDA released new guidance for devicemakers hoping to sell equipment to test for anthrax and other dangerous bacteria. Source: The GMP Letter