1. 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.”
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, ...
(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
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
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 § 809.10 - 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. 809.11 - CFR - Code of Federal Regulations Title 21 - FDA
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.
9. 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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10. 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.
11. Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate ...
6 mei 2024 · CFR: 21 CFR 809 ; Agency/Docket Number: Docket No. FDA-2024-D-0083 ; Document Number: 2024-08934 ; AGENCY: Food and Drug Administration, HHS.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564." In the context of emergent situations...
12. 809.20 - 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. 809.20 General requirements for ...
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13. [PDF] Draft Guidance for Industry and Food and Drug Administration Staff ...
" 21 CFR 809.l0(c)(2)(ii). For example, IVD products. 8. Page 9. Contains Nonbinding Recommendations. Draft - Not for Implementation under investigation that ...
14. 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 ...
15. [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) ... Part 809, In Vitro Diagnostic Products for Human Use.
16. Code of Federal Regulations > Title 21 > Chapter I > Part 809 - GovRegs
5 dagen geleden · Provides the text of the Code of Federal Regulations > Title 21 > Chapter I > Part 809 - PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE ...
Provides the text of the Code of Federal Regulations > Title 21 > Chapter I > Part 809 - PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE (CFR).
