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.”
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. 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 ...
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4. In vitro diagnostic - CFR - Code of Federal Regulations Title 21 - FDA
Sec. 809.30 Restrictions on the sale, distribution and use of analyte specific reagents. (a) Analyte specific reagents (ASR's) (§ 864.4020 of this chapter) are ...
(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."
5. 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.
6. [PDF] Food and Drug Administration 21 CFR Part 809 [Docket No. FDA-2023-N ...
Sep 29, 2023 · IVDs are also subject to specific labeling requirements in part 809 of the regulations (21 CFR part 809). D. History of the Rulemaking. 1 ...
7. 21 CFR § 809.11 - Exceptions or alternatives to labeling ...
21 CFR § 809.11 - Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.
§ 809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.
8. 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
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 ...
Awards & Memberships
10. Exceptions or Alternatives to Labeling Requirements for Products Held by ...
Dec 28, 2007 · CFR: 21 CFR 201: 21 CFR 312: 21 CFR 314: 21 CFR 601: 21 CFR 610: 21 CFR 801: 21 CFR 807: 21 CFR 809: 21 CFR 812: 21 CFR 814; Agency/Docket ...
The Food and Drug Administration (FDA) is issuing regulations to permit FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National...
11. Food and Drug Administration Regulation of in Vitro Diagnostic ...
Nov 2, 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 ...
12. Am I Complying with FDA Medical Device Labeling Requirements?
Apr 4, 2021 · 21 CFR Part 809 covers in vitro diagnostic products. Subpart B of the FDA regulation covers the labeling of those devices. This is quite an ...
How to understand and follow medical device labeling requirements from FDA for ongoing compliance.
13. 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.
14. 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 ...
List of Subjects revised as of January 1, 2024.
15. 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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16. What's on the Agenda? Laboratory Developed Tests Added to the ...
Jun 29, 2023 · (2021); H.R. 2369, 118th Cong. (2023). [17] Medical Devices; Laboratory Developed Tests, 21 C.F.R. 809 (proposed June 2023), https ...
The FDA intends to issue a notice of proposed rulemaking in August 2023 that will “make explicit” that laboratory developed tests (LDTs) are devices under the federal Food, Drug, and Cosmetic Act (FDCA).
17. [PDF] In Vitro Diagnostic (IVD) Device Studies; Draft Guidance for Industry ...
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 ...
18. FDA Medical Device Labeling requirements. - PresentationEZE
General Device Labeling – 21 CFR Part 801. In Vitro Diagnostic Products – 21 CFR Part 809. Investigational Device Exemptions – 21 CFR Part 812. Good ...
