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

Title 21Chapter ISubchapter APart 4Subpart B → §4.103


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


§4.103   What information must you share with other constituent part applicants for the combination product?

(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:

(1) A copy of the information you provided,

(2) The date the information was received by you,

(3) The date the information was provided to the other constituent part applicant(s), and

(4) The name and address of the other constituent part applicant(s) to whom you provided the information.

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