Finished device

The US quality system rules apply to manufacturers of finished devices, while component suppliers are generally outside their direct scope. The distinction therefore decides who must comply directly and who is controlled through purchasing.

Finished device means any device or accessory to any device that is suitable for use or capable of functioning.

21 CFR, 801.3

Finished device means any device or accessory to any device that is suitable for use or capable of functioning.

21 CFR, 830.3

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

21 CFR, 820.3

The 21 CFR 820.3 definition adds 'whether or not it is packaged, labeled, or sterilized', so a device counts as finished before those steps. The 801.3 and 830.3 definitions leave this phrase out.