Regulatory Affairs Professionals Society

MedCon: FDA sees uptick in class I recalls in 2025 as it tackles resourcing issues

The US Food and Drug Administration (FDA) saw more new recall events for class I medical devices in 2025 than it has in ...
Berkshire Eagle

Former top FDA official speaks in Great Barrington, calls for urgent public health action

GREAT BARRINGTON — The former director of the Food and Drug Administration's Center for Biologics Evaluation and Research has hope that the country's leaders will "wake up" and see the crucial role ...
Regulatory Affairs Professionals Society

This Week at FDA: Antibiotic impurities guidance, new nitrosamine woes, and FDA’s busy calendar

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This Week ...
Health Affairs

FDA Breakthrough Device Designation: Clinical Evidence And Medicare Payment Policies

Devices that are approved through a process that does not require any clinical evidence for FDA authorization should not automatically meet Medicare coverage criteria, which otherwise requires ...
American Hospital Association

CMS, FDA announce pathway to expedite access to certain medical devices for Medicare beneficiaries

The Centers for Medicare & Medicaid Services and the Food and Drug Administration April 23 announced a new pathway to ...