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e-CFR data is current as of February 25, 2021

Title 21Chapter ISubchapter APart 4Subpart B → §4.100


Title 21: Food and Drugs
PART 4—REGULATION OF COMBINATION PRODUCTS
Subpart B—Postmarketing Safety Reporting for Combination Products


§4.100   What is the scope of this subpart?

(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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