Reference:USA 21 CFR Part 809 06-May-2024 § 809.3 (a)
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| Document information | |
|---|---|
| Reference | USA 21 CFR Part 809 06-May-2024 |
| Validity area | USA |
| Scope(s) | G |
| Document name | 21 CFR Part 809 |
| Version / Revision | 06-May-2024 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | |
| Official source | — |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.2.3 |
| Scope | G |
| Document part | § 809.3
(a) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Scope, IVD, Definition |
Content
§ 809.3 Definitions.
(a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act (the act) and may also be biological products subject to section 351 of the Public Health Service Act, including when the manufacturer of these products is a laboratory.
