1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter A - GENERAL
  5. Part 4 - REGULATION OF COMBINATION PRODUCTS
  6. Subpart B - Postmarketing Safety Reporting for Combination Products
  7. 21 CFR § 4.100
21 CFR § 4.100
What is the scope of this subpart?
June 25, 2020
CFR

(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.

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§ 4.101 How does the FDA define key terms and phrases in this subpart?

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