---
kind: "section"
citation: "28 C.F.R. § 202.511"
title: "28"
number: "202.511"
heading: "Other clinical investigations and post-marketing surveillance data."
url: "https://uscodex.org/cfr/28/202.511"
---

# §202.511. Other clinical investigations and post-marketing surveillance data.

- (a) **Exemption.** Subparts [C](/cfr/28/subpartC.md), [D](/cfr/28/subpartD.md), J, and K (other than [§ 202.1102](/cfr/28/202.1102.md) and [§ 202.1104](/cfr/28/202.1104.md)) of this part do not apply to data transactions to the extent that those transactions are:
  - (1) Ordinarily incident to and part of clinical investigations regulated by the U.S. Food and Drug Administration (“FDA”) under sections [505(i)](/cfr/28/505.md?p=i) and [520(g)](/cfr/28/520.md?p=g) of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) or clinical investigations that support applications to the FDA for research or marketing permits for drugs, biological products, devices, combination products, or infant formula; or
  - (2) Ordinarily incident to and part of the collection or processing of clinical care data indicating real-world performance or safety of products, or the collection or processing of post-marketing surveillance data (including pharmacovigilance and post-marketing safety monitoring), and necessary to support or maintain authorization by the FDA, provided the data is de-identified or pseudonymized consistent with the standards of [21 CFR 314.80](/cfr/21/314.80.md).
- (b) **Other terms.** For purposes of this section, the terms “drug,” “biological product,” “device,” “combination product,” and “infant formula” have the meanings given to them in 21 U.S.C. [321(g)(1)](/usc/21/321.md?p=g-1), [42](/usc/21/42.md) U.S.C. 262(i)(1), 21 U.S.C. [321(h)(1)](/usc/21/321.md?p=h-1), [21](/usc/21/21.md) CFR 3.2(e), and [21 U.S.C. 321(z)](/usc/21/321.md?p=z) respectively.

## Notes

### Authority

Authority: 50 U.S.C. 1701 et seq.; 50 U.S.C. 1601 et seq.; E.O. 14117, 89 FR 15421.

### Source

Source: 90 FR 1706, Jan. 8, 2025, unless otherwise noted.