21 CFR 4.104
§ 4.104 How and where must you submit postmarketing safety reports for your combination product or constituent part?
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 4.104, § 4.104 How and where must you submit postmarketing safety reports for your combination product or constituent part?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83015
- Permanent ID
ys:prov:83015@1- SHA-256
9b5640415df4b914fd006ea9b466a57c2ffc66316774c9f8c728248f6bcbfd5c
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.