1. CFR - Code of Federal Regulations Title 21 - FDA
§ 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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2. 21 CFR Part 809 - 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.”
3. In vitro diagnostic - CFR - Code of Federal Regulations Title 21 - FDA
[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."
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. 21 CFR 809 - In-Vitro Diagnostic Products - GMP Publications
GMP Publications, Part 809 - In-Vitro Diagnostic Products.
GMP Publications, Part 809 - In-Vitro Diagnostic Products
6. [PDF] Food and Drug Administration 21 CFR Part 809 [Docket No. FDA-2023-N ...
Sep 29, 2023 · We anticipate that applying the same oversight approach to laboratories and non-laboratories that manufacture IVDs would better assure the ...
7. 21 CFR § 809.10 - Labeling for in vitro diagnostic products.
(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.
8. [PDF] Draft Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD ...
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 ...
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 ...
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10. [PDF] 2024-08934.pdf - Federal Register
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 ...