Medical Device and Diagnostic Industry (MD+DI)

FDA Issues First Update to 510(k) Exemption Guidance Since 2019

FDA adds five product codes to its premarket notification exemption list, expanding 510(k) exemptions for certain low-risk ...
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: Makary’s initiatives stay at FDA, CDRH celebrates 50 years of medtech regulations, and more

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 ...
Case Western Reserve University

FDA Approval of Aducanumab for Alzheimer’s Disease

In this Oliver C. Schroeder, Jr. Scholar-in-Residence Lecture, Michael Carome, MD, director of Public Citizen’s Health Research Group (HRG), will describe the advocacy work of HRG over the past year ...
CNET

FDA approved vs. FDA cleared: Why you need to know the difference

We're going to see a lot more consumer tech devices get the FDA's blessing. Here's what you need to know. Sarah Mitroff has worn many hats at CNET, including Senior Mobile Editor and Managing Editor ...
Ophthalmology Times

FDA grants appeal for bevacizumab-vikg BLA in neovascular AMD

The FDR outcome directs FDA divisions to finalize labeling with the sponsor, reversing the prior CRL trajectory and ...