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, ...

Regulatory Focus is the only source of timely, quality news and information fully dedicated to daily online coverage of the global regulation of healthcare products. An experienced team of reporters ...

The Medicines and Healthcare products Regulatory Agency and the US Food and Drug Administration are strengthening cooperation on medical device ...

Many Medtech startups view FDA and similar regulatory bodies as a roadblock. Something that is there to get in their way, slow them down, and cost them a fortune. Smart companies see regulations as an ...

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 ...

The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...

Apple boosts transparency by requiring regulated medical device disclosure for health apps in the EEA, UK, and US.

Additionally, DIAGNOS would like to remind the reader that the legacy version of CARA, as a Medical Image Management and Processing System, remains cleared for commercialization in the USA.

An Instagram ad catches your eye. You click to the product’s website and find reassurance: The product, it says, is "FDA certified" or was "produced in an FDA registered facility." Mention of the U.S.

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 ...