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

Title 21Chapter ISubchapter APart 4Subpart B → §4.104


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


§4.104   How and where must you submit postmarketing safety reports for your combination product or constituent part?

(a) If you are a constituent part applicant, you must submit postmarketing safety reports in accordance with the regulations identified in §4.102(b) that are applicable to your product based on its application type.

(b) If you are a combination product applicant, you must submit postmarketing safety reports required under §4.102 in the manner specified in the regulation applicable to the type of report, with the following exceptions:

(1) You must submit the postmarketing safety reports identified in §4.102(c)(1)(i) and (ii) in accordance with §314.80(g) of this chapter if your combination product received marketing authorization under an NDA or ANDA or in accordance with §600.80(h) of this chapter if your combination product received marketing authorization under a BLA.

(2) You must submit the postmarketing safety reports identified in §4.102(c)(2)(ii) and (c)(3)(ii) in accordance with §803.12(a) of this chapter if your combination product received marketing authorization under a device application.

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