(a) Exemption. Subparts C, D, J, and K (other than § 202.1102 and § 202.1104) 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) and 520(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.

(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), 42 U.S.C. 262(i)(1), 21 U.S.C. 321(h)(1), 21 CFR 3.2(e), and 21 U.S.C. 321(z) respectively.