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 ...
MedTech Dive

CMS, FDA unveil speedier Medicare coverage pathway for breakthrough devices

The pathway is designed to reduce the delay between FDA authorization and Medicare coverage for certain Class II and Class ...
Regulatory Affairs Professionals Society

FDA, CMS propose new parallel review pathway for breakthrough devices

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel ...
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 ...
JD Supra

CMS and FDA Announce RAPID Coverage Pathway to Accelerate Medicare Coverage for Breakthrough Medical Devices

Faster Medicare Coverage. The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration ...
Food

FDA limits phthalate ban to nine compounds

The FDA’s recent decision to remove 23 phthalates from food-contact uses while conducting safety assessments on remaining compounds has sparked both industry support for targeted regulation and ...