FD&C Act — Key Sections
| Section | 21 U.S.C. | Subject |
|---|---|---|
| § 201(h) | § 321(h) | Definition of "device" |
| § 502 | § 352 | Misbranded devices |
| § 510(k) | § 360(k) | Premarket notification |
| § 513 | § 360c | Classification |
| § 515 | § 360e | Premarket approval (PMA) |
| § 518(e) | § 360h(e) | Mandatory recalls |
| § 519(f) | § 360i(f) | UDI |
| § 520(b) | § 360j(b) | Custom devices |
| § 520(g) | § 360j(g) | IDE |
| § 520(m) | § 360j(m) | HDE |
| § 522 | § 360l | Post-market surveillance |