Regulatory Affairs Professionals Society

MedCon: CDRH director talks Center innovation, modernization, and new frameworks

The US Food and Drug Administration’s (FDA) top medical device official touted her center’s recent accomplishments and ...
Medical Design & Outsourcing

FDA warns device manufacturers of nitrosamine impurities that could cause cancer

FDA issued a warning to drug-device combination manufacturers about nitrosamine impurities that could increase the risk of ...
Fierce Healthcare

CMS, FDA announce new program to speed up Medicare coverage of breakthrough medical devices

The Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced on Thursday ...
RAPS

This Week at FDA: CDRH, CBER annual reports, OIG report on accelerated approval

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, ...
Medical Device and Diagnostic Industry (MD+DI)

User Fees Drive Most of the CDRH Increase in FDA’s Budget Request

FDA has released its budget request for fiscal year 2027, which would provide the agency’s Center for Devices and Radiological Health (CDRH) with an increase of more than $91 million over FY 2026.

CDRH Director Tarver previews AI guidance at AAMI event

Michelle Tarver said the device center plans to finalize guidance on AI lifecycle management and provide some initial ...
Medical Device and Diagnostic Industry (MD+DI)

The Impact of FDA's Workforce Reduction on Regulatory Timelines for Medical Device Companies

Kezar Life Sciences is a biotech, not a medical device company, but the mechanics work the same way for any company with a ...
JD Supra

FDA's Warning Letter Suggests Growing Scrutiny of AI Overreliance

Warning Letter citing a drug manufacturer for improper use of artificial intelligence (AI) suggests FDA’s scrutiny of AI is ...