JD Supra

Drug and Medical Device Regulation Under the Trump Administration

Many of President Trump’s executive orders (EOs) and legislative measures have been designed to curtail federal regulation, reduce the size of the administrative state, and withdraw the U.S. from ...
MD&M East

FDA’s New Rules for Wearables

FDA plans to limit the regulation of wearable medical devices, according to a January 6 notice from the agency. Currently, the majority of fitness tracking wearables and fitness apps are classified as ...
JD Supra

The QMSR Goes Live and FDA Implements a New Medical Device Inspection Technique

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice regulations with the international ISO 13485 standard, Medical ...
Yahoo

FDA announces regulatory exemptions for ‘non-medical grade’ devices

Add Yahoo as a preferred source to see more of our stories on Google. FDA commissioner Marty Makary made the announcement during the 2026 CES trade show The US Food and Drug Administration (FDA) is ...
MobiHealthNews

How the FDA can improve regulation of mobile health, according to FDASIA workgroup

This seems like an appropriate time to talk about what can be done to improve FDA regulation so that mobile app development can flourish. First I’ll tackle current events that make this a good time to ...
Regulatory Affairs Professionals Society

This Week at FDA: CNPV vouchers for psychedelics, progress on animal testing reduction, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
Healthline

Which Products Does the FDA Regulate?

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...
RAPS

Medical Device Data Systems to be Exempt from Regulation, FDA Says

In a stark reversal, US Food and Drug Administration (FDA) regulators today said they would exempt medical device data systems (MDDS)—systems used to collect and store data from other medical devices ...
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 ...
MobiHealthNews

Should mHealth companies want FDA regulation?

(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s ...
Case Western Reserve University

Medical Device Regulation: Going from Bad to Worse...or Better? with George Horvath

The Elena and Miles Zaremski Law Medicine Forum presents: Medical Device Regulation: Going from Bad to Worse...or Better? with George Horvath Innovations in medical device technology hold the ...
Hosted on MSN

FDA announces regulatory exemptions for 'non-medical grade' devices

The US Food and Drug Administration (FDA) is moving to relax regulatory requirements for low risk health and wellness wearables, software, and certain other non-medical grade devices. Outlining the ...