1. CFR - Code of Federal Regulations Title 21 - FDA
General requirements for manufacturers and producers of in vitro diagnostic products. § 809.30 - Restrictions on the sale, distribution and use of analyte ...
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2. 21 CFR Part 809 -- In Vitro Diagnostic Products for Human Use - eCFR
In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions.
(a) The label for an in vitro diagnostic product shall state the following information, except where such information is not applicable, or as otherwise specified in a standard for a particular product class or as provided in paragraph (e) of this section. Section 201(k) of the act provides that “a requirement made by or under authority of this act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.”
3. 21 CFR Part 809 -- In Vitro Diagnostic Products for Human Use - eCFR
Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.
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4. In vitro diagnostic - CFR - Code of Federal Regulations Title 21 - FDA
Sec. 809.3 Definitions. (a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other ...
(a) The label for an in vitro diagnostic product shall state the following information, except where such information is not applicable, or as otherwise specified in a standard for a particular product class or as provided in paragraph (e) of this section. Section 201(k) of the act provides that "a requirement made by or under authority of this act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper."
5. 21 CFR Part 809 | US Law | LII / Legal Information Institute
21 CFR Part 809 - PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE · Subpart A—General Provisions (§§ 809.3 - 809.4) · Subpart B—Labeling (§§ 809.10 - 809.11) ...
21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h, 360i, 360j, 371, 372, 374, 381.
6. [PDF] part 809—in vitro diagnostic products for human use - GovInfo
Dec 4, 1981 · PART 809—IN VITRO DIAGNOSTIC. PRODUCTS FOR HUMAN USE. Subpart A ... 21 CFR Ch. I (4–1–12 Edition). § 809.10. (iii) Instructions for a ...
7. [PDF] Food and Drug Administration 21 CFR Part 809 [Docket No. FDA-2023-N ...
Sep 29, 2023 · For devices that are subject to 510(k) requirements, a new 510(k) is only required for a significant change or modification in design,.
8. 21 CFR 809 - In-Vitro Diagnostic Products - GMP Publications
US FDA Title 21 CFR Parts Part 809 - In Vitro Diagnostic Products for Human Use. Quantity example: 211, ISBN, Drug, GMP, Etc.
GMP Publications, Part 809 - In-Vitro Diagnostic Products
9. 21 CFR § 809.11 - Exceptions or alternatives to labeling ...
21 CFR § 809.11 - Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.
§ 809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.
10. 21 CFR 809 In Vitro Diagnostic Products for Human Use with TOC
21 CFR 809 In Vitro Diagnostic Products for Human Use with TOC. Posted on March 20, 2022 April 20, 2022 by QS Compliance. View in Full Screen. Page 1 / 13.
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11. Medical Devices; Laboratory Developed Tests - Federal Register
May 6, 2024 · Food and Drug Administration. 21 CFR Part 809; [Docket No. FDA-2023-N-2177]; RIN 0910-AI85 ...
The Food and Drug Administration is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with...
12. FDA's Final Rule on Laboratory-Developed Tests
May 8, 2024 · ... 21 C.F.R. Part 809, which governs IVDs. In addition to adding ... at 37444-45 (amending 21 C.F.R. § 809.3(a)). [4] As amended, the ...
The U.S. Food and Drug Administration's highly anticipated final rule on laboratory-developed tests was officially published in the Federal Register on Monday, May 6, 2024.
13. 0910-AI85 - View Rule
CFR Citation: 21 CFR 809. Legal Authority: 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 360c ... Legal Deadline: None. Timetable: Action ...
This proposed rule would propose to amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.
14. LoS: 21 CFR - National Archives
21 CFR Part 809_In vitro diagnostic products for human use. Labeling: Medical devices; 21 CFR Part 810_Medical device recall authority. Administrative ...
Title 21: Food and Drugs List of Subjects revised as of April 1, 2024. 21 CFR Part 1_General enforcement regulations. Cosmetics Drugs Exports Food labeling Imports Incorporation by reference Labeling Reporting and recordkeeping requirements 21 CFR Part 2_General administrative rulings and decisions. Administrative practice and procedure Cosmetics Drugs Foods 21 CFR Part 3_Product jurisdiction. Administrative practice and procedure Biologics Drugs Medical devices 21 CFR Part 4_Regulation of combination products.
15. [PDF] Draft Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD ...
Oct 25, 2007 · requirements under 21 CFR Part 812 use the relevant sections of 21 CFR Part 812 regarding ... 21 CFR Part 809, In Vitro Diagnostic Products for ...
16. IVDs – A Comparison of Requirements between the US and ...
IVDs also have specific labeling requirements under 21 CFR 809 that must be complied with, prior to marketing or obtaining marketing authorization.
Get insights on the differences and similarities in IVD requirements between the US and EU markets.
17. Part 809. In Vitro Diagnostic Products For Human Use - Subchapter ... - vLex
Title 21. Food and Drugs · Chapter I. Food and Drug Administration, Department of Health and Human Services · Subchapter H. Medical Devices. Part 809. In Vitro ...
Part 809. In Vitro Diagnostic Products For Human Use [Details]. Subpart A. General Provisions. Subpart B. Labeling. Subpart C. Requirements For
18. FDA Medical Device Labeling requirements. - PresentationEZE
General Device Labeling – 21 CFR Part 801. In Vitro Diagnostic Products – 21 CFR Part 809. Investigational Device Exemptions – 21 CFR Part 812. Good ...
