part_subject: "REGULATION OF COMBINATION PRODUCTS"
subpart_code: "B"
subpart_subject: "Postmarketing Safety Reporting for Combination Products"
section_number: "4.100"
section_subject: "What is the scope of this subpart?"
cfr_reference: "21 CFR 4.100"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 1 to 99"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.