---
kind: "section"
citation: "21 C.F.R. § 4.104"
title: "21"
number: "4.104"
heading: "How and where must you submit postmarketing safety reports for your combination product or constituent part?"
url: "https://uscodex.org/cfr/21/4.104"
---

# §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)](/cfr/21/4.102.md?p=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](/cfr/21/4.102.md) 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)](/cfr/21/4.102.md?p=c-1-i) and [(ii)](/cfr/21/4.102.md?p=c-1-ii) in accordance with [§ 314.80(g)](/cfr/21/314.80.md?p=g) of this chapter if your combination product received marketing authorization under an NDA or ANDA or in accordance with [§ 600.80(h)](/cfr/21/600.80.md?p=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)](/cfr/21/4.102.md?p=c-2-ii) and [(c)(3)(ii)](/cfr/21/4.102.md?p=c-3-ii) in accordance with [§ 803.12(a)](/cfr/21/803.12.md?p=a) of this chapter if your combination product received marketing authorization under a device application.

## Notes

### Source

Source: 81 FR 92624, Dec. 20, 2016, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 360l, 360hh-360ss, 360aaa-360bbb, 360ddd, 360ddd-1, 371(a), 372-374, 379e, 381, 383, 394; 42 U.S.C. 216, 262, 263a, 264, 271.

### Source

Source: 78 FR 4321, Jan. 22, 2013, unless otherwise noted.