21 Cfr 809 (2025)

1. 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.”

2. 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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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. 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.

5. 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."

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6. [PDF] Food and Drug Administration 21 CFR Part 809 [Docket No. FDA-2023-N ...

• 29 sep 2023 · FDA is proposing to amend its regulations to make explicit that IVDs are devices under the FD&C Act including when the manufacturer of the IVD ...

7. 21 CFR § 809.3 - Definitions. - Law.Cornell.Edu

• § 809.3 Definitions. (a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other ...

• § 809.3 Definitions.

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 In Vitro Diagnostic Products for Human Use with TOC

• Introduction to Process Validation; Documentation & Audit Preparation; Mechanical Blueprint Reading; Welding Blueprint Reading; FDA Inspection ...

• Awards & Memberships

10. Medical Devices; Laboratory Developed Tests - Federal Register

• 6 mei 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...

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11. 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.

12. Food and Drug Administration Regulation of in Vitro Diagnostic ...

• 2 nov 2004 · Labeling devices in accordance with labeling regulations in 21 CFR Part 801 or 809. Submission of a premarket notification [510(k)] before ...

• The Food and Drug Administration regulates the sale and distribution of laboratory devices under a statutory and regulatory framework that is unfamiliar to most clinical laboratory scientists. In this article we briefly describe the criteria that are ...

13. PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

• Statutes, codes, and regulations · Code of Federal Regulations. •••. Title 21 - FOOD AND DRUGS CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH ...

• Browse Code of Federal Regulations | PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE for free on Casetext

14. FDA's Final Rule on Laboratory-Developed Tests

• 8 mei 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.

15. 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.

16. Part 809. In Vitro Diagnostic Products For Human Use - Subchapter ... - vLex

• Part 809. In Vitro Diagnostic Products For Human Use [Details]. Subpart ... Code of Federal Regulations · 2021 Edition · Title 21. Food and Drugs · Chapter I ...

• Part 809. In Vitro Diagnostic Products For Human Use [Details]. Subpart A. General Provisions. Subpart B. Labeling. Subpart C. Requirements For

17. [PDF] Glossary of symbols

• 19 feb 2021 · Caution: Federal law restricts this device to sale by or on the order of a physician. 21 CFR PART 809 - In vitro diagnostic products for human ...

18. Title 21 Part 809 Subpart C - Code of Federal Regulations

• PART 809 SUBPART C. CFR; ›; Title 21; ›; Volume 8; ›; Chapter I; ›; Subchapter H; ›; Part 809 ›; Subpart C. Subpart C - Requirements for Manufacturers and ...

19. FDA proposes new regulations to increase oversight of Laboratory ...

• 11 okt 2023 · ... 809, and the investigational use requirements under 21 CFR part 812 for all LDTs. ... 21 CFR parts 814 and 860 for LDTs that are classified ...

• FDA's proposed phased approach to regulating Laboratory Developed Tests (LDTs) presents a seismic shift to the viability of current going-to-market pathways for diagnostic products.

20. Navigating 2024: An Overview of the Upcoming Initiatives from FDA ...

• 1 feb 2024 · Part 801 and 809) and investigational device exemption requirements (21 C.F.R. Part 812). Stage 3 (three years after issuance of the final ...

• Navigating 2024: An Overview of the Upcoming Initiatives from FDA impacting Medical Device and IVD Manufacturers 

21. [PDF] Draft Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD ...

• 25 okt 2007 · Title 21, Code of Federal Regulations (21 CFR). Part 11 ... 21 CFR Part 809, In Vitro Diagnostic Products for Human Use, found at.