-
Regulatory Information
-
FD&C Act Chapter V: Drugs and Devices
-
Subchapter A
Drugs and Devices
- SEC. 501. [21 USC §351] Adulterated Drugs and Devices
- SEC. 502. [21 USC §352] Misbranded Drugs and Devices
- SEC. 503. [21 USC §353] Exemptions and Consideration for Certain Drugs, Devices, and Biological Products
- SEC. 503A. [21 USC §353a] Pharmacy Compounding
- SEC. 503B. [21 USC §353b] Prereview of Television Advertisements
- SEC. 504. [21 USC §354] Veterinary Feed Directive Drugs
- SEC. 505. [21 USC §355] New Drugs
- SEC. 505-1. [21 USC §355-1] Risk Evaluation and Mitigation Strategies
- SEC. 505A. [21 USC §355a] Pediatric Studies of Drugs
- SEC. 505B. [21 USC §355c] Research Into Pediatric Uses for Drugs and Biological Products
- SEC. 505C. [21 USC §355d] Internal Committee for Review of Pediatric Plans, Assessments, Deferrals, and Waivers
- SEC. 505D. [21 USC §355d] Pharmaceutical Security
- SEC. 506. [21 USC §356] Fast Track Products
- SEC. 506A. [21 USC §356a] Manufacturing Changes
- SEC. 506B. [21 USC §356b] Reports of Postmarketing Studies
- SEC. 506C. [21 USC §356c] Discontinuance of a Lifesaving Product
- SEC. 508. [21 USC §358] Authority to Designate Official Names
- SEC. 509. [21 USC §359] Nonapplicability to Cosmetics
- SEC. 510. [21 USC §360] Registration of Producers of Drugs and Devices
- SEC. 511. [21 USC §360a] Clinical Trial Guidance for Antibiotic Drugs
- SEC. 512. [21 USC §360b] New Animal Drugs
- SEC. 513. [21 USC §360c] Classification of Devices Intended for Human Use; Device Classes
- SEC. 514. [21 USC §360d] Performance Standards; Provisions of Standards
- SEC. 515. [21 USC §360e] Premarket Approval; General Requirement
- SEC. 515A. [21 USC §360e-1] Pediatric Uses of Devices
- SEC. 516. [21 USC §360f] Banned Devices; General Rule
- SEC. 517. [21 USC §360g] Judicial Review; Application of Section
- SEC. 518. [21 USC §360h] Notification and Other Remedies; Notification
- SEC. 519. [21 USC §360i] Records and Reports on Devices; General Rule
- SEC. 520. [21 USC §360j] General Provisions Respecting Control of Devices Intended for Human Use; General Rule
- SEC. 521. [21 USC §360k] State and Local Requirements Respecting Devices; General Rule
- SEC. 522. [21 USC §360l] Postmarket Surveillance
- SEC. 523. [21 USC §360m] Accredited Persons
-
-
Subchapter B
Drugs for Rare Diseases and Conditions
- SEC. 524. [21 USC §360n] Priority Review to Encourage Treatments for Tropical Diseases
- SEC. 525. [21 USC §360aa] Recommendations for Investigations of Drugs for Rare Diseases or Conditions
- SEC. 526. [21 USC §360bb] Designation of Drugs for Rare Disesases or Conditions
- SEC. 527. [21 USC §360cc] Protection for Drugs for Rare Diseases or Conditions
- SEC. 528. [21 USC §360dd] Open Protocols for Investigations of Drugs for Rare Diseases or Conditions
-
-
Subchapter C
Electronic Product Radiation Control
- SEC. 531. [21 USC §360hh] Definitions
- SEC. 532. [21 USC §360ii] Electronic Product Radiation Control Program
- SEC. 533. [21 USC §360jj] Studies by the Secretary
- SEC. 534. [21 USC §360kk] Performance Standards for Electronic Products
- SEC. 535. [21 USC §360ll] Notification of Defects in, and Repair or Replacement of, Electronic Products
- SEC. 536. [21 USC §360mm] Imports
- SEC. 537. [21 USC §360nn] Inspection and Reports
- SEC. 538. [21 USC §360oo] Prohibited Acts
- SEC. 539. [21 USC §360pp] Enforcement
- SEC. 541. [21 USC §360rr] Federal-State Cooperation
- SEC. 542. [21 USC §360ss] Effect on State Standards
-
-
Subchapter D
Dissemination of Treatment Information 1
- SEC. 551. [21 USC §360aaa] Requirements for Dissemination of Treatment Information on Drugs or Devices
- SEC. 552. [21 USC §360aaa–1] Information Authorized To Be Disseminated
- SEC. 553. [21 USC §360aaa–2] Establishment of List of Articles and Publications Disseminated and List of Providers That Received Articles and Reference Publications
- SEC. 554. [21 USC §360aaa–3] Requirement Regarding Submission of Supplemental Application for New Use; Exemption From Requirement
- SEC. 555. [21 USC §360aaa–4] Corrective Actions; Cessation of Dissemination
- SEC. 556. [21 USC §360aaa–5] Definitions
- SEC. 557. [21 USC §360aaa–6] Rules of Construction
-
-
Subchapter E
General Provisions Relating To Drugs And Devices
- SEC. 561. [21 USC §360bbb] Expanded Access to Unapproved Therapies and Diagnostics
- SEC. 562. [21 USC §360bbb–1] Dispute Resolution
- SEC. 563. [21 USC §360bbb–2] Classification of Products
- SEC. 564. [21 USC §360bbb–3] Authorization fo Medical Products for Use in Emergencies
- SEC. 565. [21 USC §360bbb–4] Technical Assistance
- SEC. 566. [21 USC §360bbb–5] Critical Path Public-Private Partnerships
- SEC. 567. [21 USC §360bbb–6] Risk communication
-
-
Subchapter F
New Animal Drugs for Minor Use and Minor Species
-
-
-