FDASIA was signed into law on July 9, 2012. This piece of legislation grants FDA the authority to collect user fees from industry to fund reviews of drugs, devices, and biologics. The changes to ...
The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...
On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous ...
When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
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