---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "ch9/schV/ptA"
level: "part"
label: "Part A"
heading: "Drugs and Devices"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/ch9-schV-ptA"
sections_count: 67
---

# Part A — Drugs and Devices

Title 21 — Food and Drugs › Chapter 9 — Federal Food, Drug, and Cosmetic Act › Subchapter V — Drugs and Devices

## Sections

- [§351. Adulterated drugs and devices](/usc/21/351.md)
- [§352. Misbranded drugs and devices](/usc/21/352.md)
- [§353. Exemptions and consideration for certain drugs, devices, and biological products](/usc/21/353.md)
- [§353a. Pharmacy compounding](/usc/21/353a.md)
- [§353a–1. Enhanced communication](/usc/21/353a-1.md)
- [§353b. Outsourcing facilities](/usc/21/353b.md)
- [§353c. Prereview of television advertisements](/usc/21/353c.md)
- [§353d. Process to update labeling for certain generic drugs](/usc/21/353d.md)
- [§354. Veterinary feed directive drugs](/usc/21/354.md)
- [§355. New drugs](/usc/21/355.md)
- [§355–1. Risk evaluation and mitigation strategies](/usc/21/355-1.md)
- [§355–2. Actions for delays of generic drugs and biosimilar biological products](/usc/21/355-2.md)
- [§355a. Pediatric studies of drugs](/usc/21/355a.md)
- [§355b. Adverse-event reporting](/usc/21/355b.md)
- [§355c. Research into pediatric uses for drugs and biological products](/usc/21/355c.md)
- [§355c–1. Report](/usc/21/355c-1.md)
- [§355d. Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers](/usc/21/355d.md)
- [§355e. Pharmaceutical security](/usc/21/355e.md)
- [§355f. Extension of exclusivity period for new qualified infectious disease products](/usc/21/355f.md)
- [§355g. Utilizing real world evidence](/usc/21/355g.md)
- [§355h. Regulation of certain nonprescription drugs that are marketed without an approved drug application](/usc/21/355h.md)
- [§356. Expedited approval of drugs for serious or life-threatening diseases or conditions](/usc/21/356.md)
- [§356–1. Accelerated approval of priority countermeasures](/usc/21/356-1.md)
- [§356–2. Accelerated approval Council](/usc/21/356-2.md)
- [§356a. Manufacturing changes](/usc/21/356a.md)
- [§356b. Reports of postmarketing studies](/usc/21/356b.md)
- [§356c. Discontinuance or interruption in the production of life-saving drugs](/usc/21/356c.md)
- [§356c–1. Annual reporting on drug shortages](/usc/21/356c-1.md)
- [§356d. Coordination; task force and strategic plan](/usc/21/356d.md)
- [§356e. Drug shortage list](/usc/21/356e.md)
- [§356f. Hospital repackaging of drugs in shortage](/usc/21/356f.md)
- [§356g. Standards for regenerative medicine and regenerative advanced therapies](/usc/21/356g.md)
- [§356h. Competitive generic therapies](/usc/21/356h.md)
- [§356i. Prompt reports of marketing status](/usc/21/356i.md)
- [§356j. Discontinuance or interruption in the production of medical devices](/usc/21/356j.md)
- [§356k. Platform technologies](/usc/21/356k.md)
- [§356l. Advanced manufacturing technologies designation program](/usc/21/356l.md)
- [§357. Qualification of drug development tools](/usc/21/357.md)
- [§358. Authority to designate official names](/usc/21/358.md)
- [§359. Nonapplicability of subchapter to cosmetics](/usc/21/359.md)
- [§360. Registration of producers of drugs or devices](/usc/21/360.md)
- [§360a. Clinical trial guidance for antibiotic drugs](/usc/21/360a.md)
- [§360a–1. Clinical trials](/usc/21/360a-1.md)
- [§360a–2. Susceptibility test interpretive criteria for microorganisms](/usc/21/360a-2.md)
- [§360b. New animal drugs](/usc/21/360b.md)
- [§360b–1. Priority zoonotic animal drugs](/usc/21/360b-1.md)
- [§360c. Classification of devices intended for human use](/usc/21/360c.md)
- [§360c–1. Reporting](/usc/21/360c-1.md)
- [§360d. Performance standards](/usc/21/360d.md)
- [§360e. Premarket approval](/usc/21/360e.md)
- [§360e–1. Pediatric uses of devices](/usc/21/360e-1.md)
- [§360e–3. Breakthrough devices](/usc/21/360e-3.md)
- [§360e–4. Predetermined change control plans for devices](/usc/21/360e-4.md)
- [§360f. Banned devices](/usc/21/360f.md)
- [§360g. Judicial review](/usc/21/360g.md)
- [§360g–1. Agency documentation and review of significant decisions regarding devices](/usc/21/360g-1.md)
- [§360g–2. Third party data transparency](/usc/21/360g-2.md)
- [§360h. Notification and other remedies](/usc/21/360h.md)
- [§360h–1. Program to improve the device recall system](/usc/21/360h-1.md)
- [§360i. Records and reports on devices](/usc/21/360i.md)
- [§360j. General provisions respecting control of devices intended for human use](/usc/21/360j.md)
- [§360k. State and local requirements respecting devices](/usc/21/360k.md)
- [§360l. Postmarket surveillance](/usc/21/360l.md)
- [§360m. Accredited persons](/usc/21/360m.md)
- [§360n. Priority review to encourage treatments for tropical diseases](/usc/21/360n.md)
- [§360n–1. Priority review for qualified infectious disease products](/usc/21/360n-1.md)
- [§360n–2. Ensuring cybersecurity of devices](/usc/21/360n-2.md)