Finished Device

Any device or accessory to a device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

Where it is written: 21 CFR 820.3(a)

Avoid This Mistake

Part 820 does not apply to manufacturers of components or parts of finished devices, though 21 CFR 820.1(a)(2) encourages them to consider its provisions.

Related terms

Manufacturer QMSR

All Terms