Code of Federal Regulations · Section
§ 830.210 — Eligibility For Use Of Fda As An Issuing Agency
21 C.F.R. § 830.210
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When FDA acts as an issuing agency, any labeler will be permitted to use FDA's unique device identification system, regardless of whether the labeler is considered a small business.
Authorizing Statute
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Definitions; generally21 U.S.C. § 321