Title 21, Food and DrugsRelease 119-73not60

§360c–1 Reporting

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

Last updated Apr 5, 2026|Official source

Summary

Each year HHS must post on the FDA website how many and what kinds of devices changed class in the previous calendar year, including law-required reclassifications.

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 21, Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60