RAPS

Custom Medical Device Definition Clarified in Final FDA Guidance

The US Food and Drug Administration (FDA) has issued a new final guidance document intended to clarify the process by which manufacturers of "custom" medical devices can comply with federal ...
RAPS

FDA clarifies definition of devices vs. counterfeit devices

The US Food and Drug Administration has published draft guidance updating its definition of a device in accordance with the 2021 Safeguarding Therapeutics Act.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 – ...