21 Cfr 809 (2024)

Table of Contents
1. 21 CFR Part 809 -- In Vitro Diagnostic Products for Human Use - eCFR 2. CFR - Code of Federal Regulations Title 21 - FDA 3. 21 CFR Part 809 | US Law | LII / Legal Information Institute 4. In vitro diagnostic - CFR - Code of Federal Regulations Title 21 - FDA 5. CFR - Code of Federal Regulations Title 21 - FDA 6. 21 CFR 809 - In-Vitro Diagnostic Products - GMP Publications 7. [PDF] Food and Drug Administration 21 CFR Part 809 [Docket No. FDA-2023-N ... 8. 809.11 - CFR - Code of Federal Regulations Title 21 - FDA 9. 21 CFR 809 In Vitro Diagnostic Products for Human Use with TOC 10. Subpart B—Labeling | Electronic Code of Federal Regulations (e-CFR) 11. 809.30 - CFR - Code of Federal Regulations Title 21 - FDA 12. Medical Devices; Laboratory Developed Tests - Federal Register 13. IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE - Chan Robles 14. [PDF] Draft Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD ... 15. 809.20 - CFR - Code of Federal Regulations Title 21 - FDA 16. PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE 17. In Vitro Diagnostic Device Labeling Requirements - FDA 18. FDA's Final Rule on Laboratory-Developed Tests 19. 0910-AI85 - View Rule 20. Title 21 Part 809 Subpart C - Code of Federal Regulations 21. 809.4 - CFR - Code of Federal Regulations Title 21 - FDA 22. FDA's Final Rule and LDT Regulation Shift - The National Law Review 23. FDA proposes new regulations to increase oversight of Laboratory ... 24. Am I Complying with FDA Medical Device Labeling Requirements?

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

  • 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 ...

  • -

3. 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.

4. 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, including a ...

  • (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. CFR - Code of Federal Regulations Title 21 - FDA

  • PART 809 -- IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE. Subpart A - General Provisions. Sec. 809.3 Definitions. (a) In vitro diagnostic products are those ...

  • -

6. 21 CFR 809 - In-Vitro Diagnostic Products - GMP Publications

7. [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 ...

8. 809.11 - CFR - Code of Federal Regulations Title 21 - FDA

  • 809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile. (a) The ...

  • (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.

  • Awards & Memberships

10. Subpart B—Labeling | Electronic Code of Federal Regulations (e-CFR)

  • PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE; Subpart B—Labeling. 21 CFR Subpart B - Subpart B—Labeling. CFR. prev | next · § 809.10 Labeling for in ...

  • Please help us improve our site!

11. 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.

12. Medical Devices; Laboratory Developed Tests - Federal Register

  • 6 mei 2024 · ... regulations. IVDs are also subject to specific labeling requirements in part 809 of the regulations (21 CFR part 809). For additional ...

  • The Food and Drug Administration is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with...

13. IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE - Chan Robles

  • 21 C.F.R. PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE. TITLE 21--Food and Drugs. CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND ...

  • US LAWS, STATUTES & CODES ON-LINE : chanrobles.com

14. [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) ... 21 CFR Part 809, In Vitro Diagnostic Products for Human Use, ...

15. 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 ...

  • -

16. PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

  • Browse Code of Federal Regulations | PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE for free on Casetext. ... Title 21 - FOOD AND DRUGS CHAPTER I - FOOD ...

  • Browse Code of Federal Regulations | PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE for free on Casetext

17. In Vitro Diagnostic Device Labeling Requirements - FDA

  • 25 jul 2023 · ... 21 CFR Part 809. Numbers appearing in parentheses next to subject headings are the corresponding sections of 21 CFR. This section contains ...

  • Information about In Vitro diagnostic device labeling requirements.

18. FDA's Final Rule on Laboratory-Developed Tests

  • 8 mei 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.

19. 0910-AI85 - View Rule

  • 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.

20. Title 21 Part 809 Subpart C - Code of Federal Regulations

  • PART 809 SUBPART C. CFR; ›; Title 21; ›; Volume 8; ›; Chapter I; ›; Subchapter H; ›; Part 809 ›; Subpart C. Subpart C - Requirements for Manufacturers and ...

21. 809.4 - CFR - Code of Federal Regulations Title 21 - FDA

  • PART 809 -- IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE. Subpart A - General Provisions. Sec. 809.4 Confidentiality of submitted information. Data and ...

  • -

22. FDA's Final Rule and LDT Regulation Shift - The National Law Review

  • 30 apr 2024 · [8] See 21 CFR Part 807. [9] See 21 CFR Parts 801 and 809, Subpart B. [10] See 21 CFR Part 812. [11] See ...

  • Yesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage plan that will phase out the Agency’s previous policy of enforcement discretion for Laboratory-Developed Tests (“LDTs”). The final rule was issued at an astonishing speed compared to FDA’s usual rulemaking timeline,[1] coming not even six months after FDA issued the proposed rule.

23. FDA proposes new regulations to increase oversight of Laboratory ...

  • 11 okt 2023 · ... 809, and the investigational use requirements under 21 CFR part 812 for all LDTs. ... 21 CFR parts 814 and 860 for LDTs that are classified ...

  • FDA's proposed phased approach to regulating Laboratory Developed Tests (LDTs) presents a seismic shift to the viability of current going-to-market pathways for diagnostic products.

24. Am I Complying with FDA Medical Device Labeling Requirements?

  • 4 apr 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.

21 Cfr 809 (2024)
Top Articles
Latest Posts
Article information

Author: Eusebia Nader

Last Updated:

Views: 6385

Rating: 5 / 5 (60 voted)

Reviews: 83% of readers found this page helpful

Author information

Name: Eusebia Nader

Birthday: 1994-11-11

Address: Apt. 721 977 Ebert Meadows, Jereville, GA 73618-6603

Phone: +2316203969400

Job: International Farming Consultant

Hobby: Reading, Photography, Shooting, Singing, Magic, Kayaking, Mushroom hunting

Introduction: My name is Eusebia Nader, I am a encouraging, brainy, lively, nice, famous, healthy, clever person who loves writing and wants to share my knowledge and understanding with you.