Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (h)
From GxPlex
| Document information | |
|---|---|
| Reference | USA U.S. Code Title 21 30-Sep-2023 |
| Validity area | USA |
| Scope(s) | G |
| Document name | U.S. Code Title 21 |
| Version / Revision | 30-Sep-2023 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | U.S. Code Title 21 - Food and Drugs |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.2.3 |
| Scope | G |
| Document part | § 321 (h) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Scope, Medical device, Definition |
Content
(h)(1) The term ‘‘device’’ (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—
(A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
The term ‘‘device’’ does not include software functions excluded pursuant to section 360j(o) of this title.
