Regulatory Information
FD&C Act Chapter V: Drugs and Devices
- Part A - Drugs and Devices (sections 351 - 360n)
- Part B - Drugs for Rare Diseases or Conditions (sections 360aa - 360ee)
- Part C - Electronic Product Radiation Control (sections 360hh - 360ss)
- Part D - Dissemination of Treatment Information (sections 360aaa - 360aaa-6)
- Part E - General Provisions Relating to Drugs and Devices (sections 360bbb - 360bbb-6)
- Part F - New Animal Drugs for Minor Use and Minor Species (sections 360ccc - 360ccc-2)
Part A - Drugs and Devices (sections 351 - 360n)
FD&C Act Section number | Title | Reference |
|---|---|---|
Sec. 501 | Sec. 351 - Adulterated drugs and devices | PDF | Text | More Information |
Sec. 502 | Sec. 352 - Misbranded drugs and devices | PDF | Text | More Information |
Sec. 503 | Sec. 353 - Exemptions and consideration for certain drugs, devices, and biological products | PDF | Text | More Information |
Sec. 503A | Sec. 353a - Pharmacy compounding | PDF | Text | More Information |
Sec. 503B | Sec. 353b - Prereview of television advertisements | PDF | Text | More Information |
Sec. 504 | Sec. 354 - Veterinary feed directive drugs | PDF | Text | More Information |
Sec. 505 | Sec. 355 - New drugs | PDF | Text | More Information |
| Sec. 355-1 - Risk evaluation and mitigation strategies | PDF | Text | More Information |
Sec. 505A | Sec. 355a - Pediatric studies of drugs | PDF | Text | More Information |
| Sec. 355b - Adverse-event reporting | PDF | Text | More Information |
Sec. 505B | Sec. 355c - Research into pediatric uses for drugs and biological products | PDF | Text | More Information |
Sec. 505C | Sec. 355d - Internal committee for review of pediatric plans, assessments, deferrals, and waivers | PDF | Text | More Information |
Sec. 505D | Sec. 355e - Pharmaceutical security | PDF | Text | More Information |
Sec. 506 | Sec. 356 - Fast track products | PDF | Text | More Information |
| Sec. 356-1 - Accelerated approval of priority countermeasures | PDF | Text | More Information |
Sec. 506A | Sec. 356a - Manufacturing changes | PDF | Text | More Information |
Sec. 506B | Sec. 356b - Reports of postmarketing studies | PDF | Text | More Information |
Sec. 506C | Sec. 356c - Discontinuance of life saving product | PDF | Text | More Information |
| Sec. 357 - Repealed. Pub. L. 105-115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325 | PDF | Text | More Information |
Sec. 508 | Sec. 358 - Authority to designate official names | PDF | Text | More Information |
Sec. 509 | Sec. 359 - Nonapplicability of subchapter to cosmetics | PDF | Text | More Information |
Sec. 510 | Sec. 360 - Registration of producers of drugs or devices | PDF | Text | More Information |
Sec. 511 | Sec. 360a - Clinical trial guidance for antibiotic drugs | PDF | Text | More Information |
Sec. 512 | Sec. 360b - New animal drugs | PDF | Text | More Information |
Sec. 513 | Sec. 360c - Classification of devices intended for human use | PDF | Text | More Information |
Sec. 514 | Sec. 360d - Performance standards | PDF | Text | More Information |
Sec. 515 | Sec. 360e - Premarket approval | PDF | Text | More Information |
Sec. 515A | Sec. 360e-1 - Pediatric uses of devices | PDF | Text | More Information |
Sec. 516 | Sec. 360f - Banned devices | PDF | Text | More Information |
Sec. 517 | Sec. 360g - Judicial review | PDF | Text | More Information |
Sec. 518 | Sec. 360h - Notification and other remedies | PDF | Text | More Information |
Sec. 519 | Sec. 360i - Records and reports on devices | PDF | Text | More Information |
Sec. 520 | Sec. 360j - General provisions respecting control of devices intended for human use | PDF | Text | More Information |
Sec. 521 | Sec. 360k - State and local requirements respecting devices | PDF | Text | More Information |
Sec. 522 | Sec. 360l - Postmarket surveillance | PDF | Text | More Information |
Sec. 523 | Sec. 360m - Accredited persons | PDF | Text | More Information |
Sec. 524 | Sec. 360n - Priority review to encourage treatments for tropical diseases | PDF | Text | More Information |
Part B - Drugs for Rare Diseases or Conditions (sections 360aa - 360ee)
FD&C Act Section number | Title | Reference |
|---|---|---|
Sec. 525 | Sec. 360aa - Recommendations for investigations of drugs for rare diseases or conditions | PDF | Text | More Information |
Sec. 526 | Sec. 360bb - Designation of drugs for rare diseases or conditions | PDF | Text | More Information |
Sec. 527 | Sec. 360cc - Protection for drugs for rare diseases or conditions | PDF | Text | More Information |
Sec. 528 | Sec. 360dd - Open protocols for investigations of drugs for rare diseases or conditions | PDF | Text | More Information |
| Sec. 360ee - Grants and contracts for development of drugs for rare diseases and conditions | PDF | Text | More Information |
Part C - Electronic Product Radiation Control (sections 360hh - 360ss)
FD&C Act Section number | Title | Reference |
|---|---|---|
Sec. 531 | Sec. 360hh - Definitions | PDF | Text | More Information |
Sec. 532 | Sec. 360ii - Program of control | PDF | Text | More Information |
Sec. 533 | Sec. 360jj - Studies by Secretary | PDF | Text | More Information |
Sec. 534 | Sec. 360kk - Performance standards for electronic products | PDF | Text | More Information |
Sec. 535 | Sec. 360ll - Notification of defects in and repair or replacement of electronic products | PDF | Text | More Information |
Sec. 536 | Sec. 360mm - Imports | PDF | Text | More Information |
Sec. 537 | Sec. 360nn - Inspection, records, and reports | PDF | Text | More Information |
Sec. 538 | Sec. 360oo - Prohibited acts | PDF | Text | More Information |
Sec. 539 | Sec. 360pp - Enforcement | PDF | Text | More Information |
| Sec. 360qq - Repealed. Pub. L. 105-362, title VI, §601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285 | PDF | Text | More Information |
Sec. 541 | Sec. 360rr - Federal-State cooperation | PDF | Text | More Information |
Sec. 542 | Sec. 360ss - State standards | PDF | Text | More Information |
Part D - Dissemination of Treatment Information (sections 360aaa - 360aaa-6)
FD&C Act Section number | Title | Reference |
|---|---|---|
| Secs. 360aaa to 360aaa-6 - Omitted | PDF | Text | More Information |
Part E - General Provisions Relating to Drugs and Devices (sections 360bbb - 360bbb-6)
FD&C Act Section number | Title | Reference |
|---|---|---|
Sec. 561 | Sec. 360bbb - Expanded access to unapproved therapies and diagnostics | PDF | Text | More Information |
Sec. 652 | Sec. 360bbb-1 - Dispute resolution | PDF | Text | More Information |
Sec. 563 | Sec. 360bbb-2 - Classification of products | PDF | Text | More Information |
Sec. 564 | Sec. 360bbb-3 - Authorization for medical products for use in emergencies | PDF | Text | More Information |
Sec. 565 | Sec. 360bbb-4 - Technical assistance | PDF | Text | More Information |
Sec. 566 | Sec. 360bbb-5 - Critical Path Public-Private Partnerships | PDF | Text | More Information |
Sec. 567 | Sec. 360bbb-6 - Risk communication | PDF | Text | More Information |
Part F - New Animal Drugs for Minor Use and Minor Species (sections 360ccc - 360ccc-2)
FD&C Act Section number | Title | Reference |
|---|---|---|
Sec. 571 | Sec. 360ccc - Conditional approval of new animal drugs for minor use and minor species | PDF | Text | More Information |
Sec. 572 | Sec. 360ccc-1 - Index of legally marketed unapproved new animal drugs for minor species | PDF | Text | More Information |
Sec. 573 | Sec. 360ccc-2 - Designated new animal drugs for minor use or minor species | PDF | Text | More Information |
