The US Food and Drug Administration has published draft guidance updating its definition of a device in accordance with the 2021 Safeguarding Therapeutics Act. The document – published 10 November – ...
The FDA is set to exempt certain types of software from regulatory oversight as it reconsiders its approach to products on the fringes of the medical device sector. Officials at the agency set out ...
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In 1976, Congress enacted the Medical Device Amendments (MDA). This law, now part of the Federal Food, Drug, and Cosmetic Act (FD&C Act), generally requires FDA clearance or approval before a new ...
A medical device is any appliance, apparatus, software, material, or other articles, which may be used in isolation or combination (as defined by the manufacturer) by individuals for a medical purpose ...
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