part_subject: "REGULATION OF COMBINATION PRODUCTS"
subpart_code: "B"
subpart_subject: "Postmarketing Safety Reporting for Combination Products"
section_number: "4.103"
section_subject: "What information must you share with other constituent part applicants for the combination product?"
cfr_reference: "21 CFR 4.103"
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)When you receive information regarding an event that involves a death or serious injury as described in § 803.3 of this chapter, or an adverse experience as described in § 314.80(a) of this chapter or § 600.80(a) of this chapter, associated with the use of the combination product, you must provide the information to the other constituent part applicant(s) for the combination product no later than 5 calendar days of your receipt of the information.
(b)With regard to information you must provide to the other constituent part applicant(s) for the combination product, you must maintain records that include: