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 ...
-
2. 21 CFR Part 809 - eCFR
No information is available for this page. · Learn why
(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 § 809.10 - 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.
6. 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
7. [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,.
8. 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
9. [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 ...
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 ...
11. 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.
12. 21 CFR Part 809 IVD - お役立ち情報
Feb 18, 2019 · 21 CFR Part 809 IVD · Part 809 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USEとは · Part 809 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE目次.
Part 809 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USEとはIVD製品に関する追加の規定を提供part801に追加してIVD製品に要求されるラベル・ラベリングへの記載事項が大部分を占め...
13. 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.
