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.”

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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(a) 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."

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.

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

29 sep 2023 · Act and FDA's regulations. IVDs are also subject to specific labeling requirements in part 809 of the regulations (21 CFR part 809). D ...

PART 809 -- IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE. Subpart B - Labeling. Sec. 809.11 Exceptions or alternatives to labeling requirements for in vitro ...
(a) The appropriate FDA Center Director may grant an exception or alternative to any provision listed in paragraph (f) of this section and not explicitly required by statute, for specified lots, batches, or other units of an in vitro diagnostic product for human use, if the Center Director determines that compliance with such labeling requirement could adversely affect the safety, effectiveness, or availability of such products that are or will be included in the Strategic National Stockpile.

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES · SUBCHAPTER H—MEDICAL DEVICES · PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN ...
§ 809.20 General requirements for manufacturers and producers of in vitro diagnostic products.

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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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.