Medical Device and Diagnostic Industry (MD+DI)

Understanding FDA's QMSR and Cybersecurity Mandates for Medical Devices

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

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 ...
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 ...
Medical Design & Outsourcing

FDA’s new guidance on consumer wearables makes the medtech market more complex

Instead of making life easier for medical device companies, the FDA’s new wearables guidance makes the market more complex.

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 ...
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 ...
GlobalData on MSN

Portal Diabetes’ insulin pump receives FDA breakthrough device designation

The designation supports priority engagement with the FDA as Portal Diabetes advances clinical trials and regulatory submissions.
ConsumerAffairs

FDA relaxes rules for wearable health devices

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices. Officials say the move is intended to speed innovation while maintaining ...