2022—Subsec. (a)(1). Pub. L. 117–328 amended par. (1) generally. Prior to amendment, text read as follows: “The Secretary shall provide a substantive summary of the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding submission or review of a report under section 360(k) of this title, an application under section 360e of this title, a request for designation under section 360e–3 of this title, or an application for an exemption under section 360j(g) of this title, including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion.”

2016—Subsec. (a)(1). Pub. L. 114–255, § 3051(b), inserted “a request for designation under section 360e–3 of this title,” after “application under section 360e of this title,”.

Subsec. (a)(3). Pub. L. 114–255, § 3058(c), added par. (3).