21 CFR 4.100
§ 4.100 What is the scope of this subpart?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 4.100, § 4.100 What is the scope of this subpart?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83011
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Full text
(a) This subpart identifies postmarketing safety reporting requirements for combination product applicants and constituent part applicants.
(b) This subpart does not apply to investigational combination products, combination products that have not received marketing authorization, or to persons other than combination product applicants and constituent part applicants.
(c) This subpart supplements and does not supersede other provisions of this chapter, including the provisions in parts 314, 600, 606, 803, and 806 of this chapter, unless a regulation explicitly provides otherwise.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.