21 Cfr 809 (2024)

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

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(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.”

§ 809.20 - 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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[CITE: 21CFR809]. TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H - MEDICAL DEVICES. PART ...
(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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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.

(a) The label for an in vitro diagnostic product shall state the following information, except where such information is not applicable, or as otherwise ...
§ 809.10 Labeling for in vitro diagnostic products.

Sep 29, 2023 · We anticipate that applying the same oversight approach to laboratories and non-laboratories that manufacture IVDs would better assure the ...
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Oct 25, 2007 · 21 CFR Part 809, In Vitro Diagnostic Products for Human Use, found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm ...

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Apr 29, 2024 · 21 CFR Part 809. [Docket No. FDA-2024-D-0083]. Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health. Response ...

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.

21 CFR 801 and 809 Labeling. 21 CFR 803 Reporting. 21 CFR 807 Establishment Registration & Device Listing. 21 CFR 809 In Vitro Diagnostic Products for Human Use.

SUPPORTING STATEMENT. FOR. MEDICAL DEVICE LABELING REGULATIONS. 21 CFR PARTS 800, 801, AND 809. OMB NUMBER 0910-0485.

Apr 6, 1998 · use language in accordance with either21 CFR 809. 10(c)(ii) or 21 CFR 812.5 be used. In the former case, where the product is used in the ...