21 Cfr 809 (2024)

1. 21 CFR Part 809 -- In Vitro Diagnostic Products for Human Use - eCFR

• General requirements for manufacturers and producers of in vitro diagnostic products. § 809.30, Restrictions on the sale, distribution and use of analyte ...

• (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

• 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 ...

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3. In vitro diagnostic - CFR - Code of Federal Regulations Title 21 - FDA

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

• (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."

4. 21 CFR Part 809 -- In Vitro Diagnostic Products for Human Use - eCFR

• General requirements for manufacturers and producers of in vitro diagnostic products. § 809.30, Restrictions on the sale, distribution and use of ...

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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. 21 CFR 809 - In-Vitro Diagnostic Products - GMP Publications

• 21 CFR 809 - In-Vitro Diagnostic Products. 10Part809-1.jpg 1-933734-46-9. US FDA Title 21 CFR Parts. Part 809 - In Vitro Diagnostic Products for Human Use ...

• GMP Publications, Part 809 - In-Vitro Diagnostic Products

7. CFR - Code of Federal Regulations Title 21 - FDA

• PART 809 -- IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE. Subpart A - General Provisions. Sec. 809.3 Definitions. (a) In vitro diagnostic products are those ...

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8. [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 ...

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. 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...

11. 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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12. 809.30 - CFR - Code of Federal Regulations Title 21 - FDA

• PART 809 -- IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE. Subpart C - Requirements for Manufacturers and Producers. Sec. 809.30 Restrictions on the sale ...

• (a) Analyte specific reagents (ASR's) (§ 864.4020 of this chapter) are restricted devices under section 520(e) of the Federal Food, Drugs, and Cosmetic Act (the act) subject to the restrictions set forth in this section.

13. Regulations for medical device clinical investigations | FAQs - Proxima CRO

• Any other applicable regulations, including pertinent sections of In Vitro Diagnostic Devices for Human Use (21 CFR 809). States may have their own laws ...

• What statute and regulations apply to medical device clinical investigations? Clinical studies of medical devices must comply with:

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

• 25 okt 2007 · This is not an all-inclusive list. Title 21, Code of Federal Regulations (21 CFR) ... 21 CFR Part 809, In Vitro Diagnostic Products for Human Use, ...