The FDA has issued a final guidance on postmarketing safety reporting (PMSR) requirements for combination products. Source: The GMP Letter

With only nine months to go before the EU’s Medical Device Regulation hits its May 26 application date, the U.S. is pressing the EU to delay implementation for another three…

After months of criticism of the European Commission for the slow release of guidance on the EU’s new medical device regulations, the Commission released a flurry of documents on the…

Covington & Burling attorney Pamela Forrest offered insights into when devicemakers must file recall reports with the FDA to comply with 21 CFR Part 806 in a recent FDAnews webinar,…

The FDA cited four devicemakers following inspections that revealed problems with process controls, validations, complaint handling and medical devices reports. Source: The GMP Letter

A combination of real-world evidence and periodic reporting to the FDA should be the cornerstone of how the agency regulates AI and machine learning in software as a medical device,…

GS1 released updated guidance to help devicemakers comply with new unique device identifier requirements under the FDA’s updated standards. Source: The GMP Letter

The shortage of notified bodies to certify devices for the new EU medical device and IVD regulations appears to be reaching crisis point as more notified bodies say they won’t…

CDER’s associate director for data analysis, Karthik Iyer, urged drugmakers to sign up for the agency’s quality metrics feedback program and the quality metrics site visit program, in a presentation…

Health Canada is increasing fees for device sponsors and will peg ongoing increases to inflation, the agency said in a final report on the planned changes. Source: The GMP Letter