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The US Food and Drug Administration has published draft guidance updating its definition of a device in accordance with the 2021 Safeguarding Therapeutics Act.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

The Custom Device Exemption: What Is It And Does It Ever Apply?

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 ...
PC Magazine

device management

(1) Within the computer, activating and controlling the peripheral devices. In a desktop computer, the operating system interacts with the device drivers for peripheral control. In very small embedded ...