§821.1. Scope. — Inbound Citations
21 C.F.R. § 821.1
Statutory Authority
Cited by 1 regulation in release Current.
Citations to §821.1(a)
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(a) A manufacturer of any class II or class III device that fits within one of the three criteria within § 821.1(a) must track that device in accordance with this part, if FDA issues a tracking order to that manufacturer.