Title 21Food and DrugsRelease 119-73

§360c–1 Reporting

Title 21 › Chapter CHAPTER 9— - FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER V— - DRUGS AND DEVICES › Part Part A— - Drugs and Devices › § 360c–1

Last updated Apr 6, 2026|Official source

Summary

Each year the HHS Secretary must post on the FDA website the number and type of devices reclassified in the previous calendar year: class I/II to II/III and class II/III to I/II under section 360c(e)(1), and reclassifications under section 360e.

Full Legal Text

Title 21, §360c–1

Food and Drugs — Source: USLM XML via OLRC

The Secretary of Health and Human Services shall annually post on the Internet Web site of the Food and Drug Administration—
(1)the number and type of class I and class II devices reclassified as class II or class III in the previous calendar year under section 360c(e)(1) of this title;
(2)the number and type of class II and class III devices reclassified as class I or class II in the previous calendar year under such section 360c(e)(1) of this title; and
(3)the number and type of devices reclassified in the previous calendar year under section 360e of this title.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Codification Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Reference

Citations & Metadata

Citation

21 U.S.C. § 360c–1

Title 21Food and Drugs

Last Updated

Apr 6, 2026

Release point: 119-73