FDA Eases Wellness Device Regulation, But Marketing Is Still Key

Opinion: The Food and Drug Administration's updated guidance on wellness devices will help ensure that products are appropriately positioned in the market—while staying away from unsupported, ...
Medical Device and Diagnostic Industry (MD+DI)

Medical Device Companies Must Navigate Historic FDA Rule Change

FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...
IEEE Spectrum on MSN

What the FDA’s 2026 update means for wearables

Simpler rules apply to less invasive hardware ...

Facet Life Sciences Publishes Second Edition of FDA and Intellectual Property Strategies for Medical Device Technologies

Facet Life Sciences, a regulatory affairs and product development strategy partner, is proud to announce the release of the second edition of FDA and Intellectual Property Strategies for Medical ...
HealthLeaders Media

FDA relaxes rules for wearable health devices

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...
Mad in AmericaOpinion

The FDA Allows Ineffective Devices to Come to Market

The main take-home message is that regulatory approval doesn't mean a device works. It means it's safe,” according to Katya ...
MobiHealthNews

Three key questions for FDA mHealth regulation

The mHealth Regulatory Coalition (MRC) recently released “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth," which is a 60-page paper that focuses on two fundamental ...

Dangerous medical implants and devices

For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and ...