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.”
2. 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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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.
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5. 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.
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6. [PDF] Food and Drug Administration 21 CFR Part 809 [Docket No. FDA-2023-N ...
Sep 29, 2023 · For devices that are subject to 510(k) requirements, a new 510(k) is only required for a significant change or modification in design,.
7. 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
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. Fair Debt Collection Practices Act | Federal Trade Commission
§ 809. Validation of debts. (a) Notice of debt; contents. Within five days after the initial communication with a consumer in connection with the collection of ...
See AlsoAvis sur le film Evil Dead RiseFair Debt Collection Practices Act As amended by Public Law 111-203, title X, 124 Stat.
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10. FDA Regulation of Clinical Microbiology Diagnostic Devices
The Code of Federal Regulations (21 CFR 809.3) ... Part 809. In vitro diagnostic products for human ... Title 21. Food and Drugs. Chapter I. Food and Drug ...
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11. Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate ...
May 6, 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...
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12. View Rule - RegInfo.gov
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.
13. Geographic Distribution of Suspected Alpha-gal Syndrome Cases - CDC
Jul 28, 2023 · 45 C.F.R. part 46, 21 C.F.R. part 56; 42 U.S.C. Sect. 241(d); 5 ... MMWR Morb Mortal Wkly Rep 2023;72:809–14. https://www.cdc.gov/mmwr ...
This report describes the number of suspected Alpha ...
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14. FDA's Final Rule on Laboratory-Developed Tests
May 8, 2024 · ... 21 C.F.R. Part 809, which governs IVDs. In addition to adding ... at 37444-45 (amending 21 C.F.R. § 809.3(a)). [4] As amended, the ...
The U.S. Food and Drug Administration's highly anticipated final rule on laboratory-developed tests was officially published in the Federal Register on Monday, May 6, 2024.
![FDA's Final Rule on Laboratory-Developed Tests](https://i0.wp.com/www.gibsondunn.com/wp-content/uploads/2023/10/10.06.23_NewsAlert_FDA-Rule-on-Medica-Device-Jurisdiction-over-LDTs.jpg)
15. LoS: 21 CFR - National Archives
21 CFR Part 809_In vitro diagnostic products for human use. Labeling: Medical devices; 21 CFR Part 810_Medical device recall authority. Administrative ...
Title 21: Food and Drugs List of Subjects revised as of April 1, 2024. 21 CFR Part 1_General enforcement regulations. Cosmetics Drugs Exports Food labeling Imports Incorporation by reference Labeling Reporting and recordkeeping requirements 21 CFR Part 2_General administrative rulings and decisions. Administrative practice and procedure Cosmetics Drugs Foods 21 CFR Part 3_Product jurisdiction. Administrative practice and procedure Biologics Drugs Medical devices 21 CFR Part 4_Regulation of combination products.
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