21 Cfr 809 (2025)

1. 21 CFR Part 809 -- In Vitro Diagnostic Products for Human Use - eCFR

  • 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.”

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

  • General requirements for manufacturers and producers of in vitro diagnostic products. § 809.30 - Restrictions on the sale, distribution and use of analyte ...

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3. 21 CFR Part 809 -- In Vitro Diagnostic Products for Human Use - eCFR

4. In vitro diagnostic - CFR - Code of Federal Regulations Title 21 - FDA

  • Sec. 809.3 Definitions. (a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other ...

  • (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.

21 CFR Part 809 | US Law | LII / Legal Information Institute

6. [PDF] Food and Drug Administration 21 CFR Part 809 [Docket No. FDA-2023-N ...

7. 21 CFR 809 - In-Vitro Diagnostic Products - GMP Publications

  • US FDA Title 21 CFR Parts Part 809 - In Vitro Diagnostic Products for Human Use. Quantity example: 211, ISBN, Drug, GMP, Etc.

  • GMP Publications, Part 809 - In-Vitro Diagnostic Products

8. 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.

21 CFR § 809.11 - Exceptions or alternatives to labeling ...

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. Medical Devices; Laboratory Developed Tests - Federal Register

  • May 6, 2024 · Food and Drug Administration. 21 CFR Part 809; [Docket No. FDA-2023-N-2177]; RIN 0910-AI85 ...

  • 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...

Medical Devices; Laboratory Developed Tests - Federal Register

11. 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

12. 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.

21 Cfr 809 (2025)

FAQs

What is 21 CFR 809? ›

PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE.

What is the CFR for IVD? ›

§ 201.119 In vitro diagnostic products. (a) “In vitro diagnostic products” are those reagents, instruments and systems intended for use in the diagnosis of disease or in the determination of the state of health in order to cure, mitigate, treat, or prevent disease or its sequelae.

What is 21 CFR Part 11 conformance for medical devices? ›

21 CFR Part 11 is a U.S. federal regulation specifying FDA guidelines for electronic Records and Signatures. The regulation applies to pharmaceutical companies and medical device manufacturers, and it requires the companies to implement controls that ensure the integrity of their documents.

What is the 21 CFR for medical devices? ›

Most of FDA's medical device and radiation-emitting product regulations are in Title 21 CFR Parts 800-1299. These final regulations codified in the CFR cover various aspects of design, clinical evaluation, manufacturing, packaging, labeling and post market surveillance of medical devices.

What does CFR 21 cover? ›

The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.. Title 21 of the CFR is reserved for rules of the Food and Drug Administration.

What is 21 CFR indication for use? ›

(i) Indications for use. A general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.

Which of 21 CFR parts applies to biologics only? ›

PART 600—BIOLOGICAL PRODUCTS: GENERAL.

What does CFR stand for? ›

The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.

Is IVD FDA approved? ›

Most Class II IVDs are approved through the Premarket notification or 510(k) process. A 510(k) is a premarket submission made to the FDA to demonstrate that the diagnostic devices to be marketed are at least as safe and effective, Substantially Equivalent (SE), to a legally marketed one.

What is the difference between 21 CFR Part 11 and 21 CFR Part 820? ›

Part 11 deals with electronic records and electronic signatures, and Part 820 deals with establishment of a quality management system. Both parts play a role in governing how calibration of measuring instruments should be handled, and are effectively addressed by GageList FDA calibration software.

Who does 21 CFR Part 11 apply to? ›

The FDA 21 CFR Part 11 requirements apply to companies operating in FDA-regulated industries using electronic records and electronic signatures (eSignatures). In the Life Sciences, those include pharmaceutical, biotechnological, medical device, and other industries.

What is the difference between GMP and 21 CFR Part 11? ›

Specifically, 21 CFR Part 11 governs electronic records and signatures in the FDA-regulated landscape and is more specific, while EU GMP Annex 11 guides computerized systems in the EU's GMP-regulated activities focusing on general guidance, effective implementation, and validation.

What is CFR 21 compliance? ›

CFR stands for “Code of Federal Regulation.” 21 CFR Part 11, in particular, details the criteria under which electronic records and signatures are considered to be trustworthy and equivalent to paper records.

What is the summary of 21 CFR? ›

The term “21 CFR” refers to Title 21 of the Code of Federal Regulations (CFR), a list of operational requirements that an FDA-regulated manufacturing company must comply with to produce and sell products to consumers. You may also hear it referred to as “CFR Title 21.”

What are the benefits of 21 CFR Part 11? ›

Benefits of 21 CFR Part 11
  • Increased data confidentiality, integrity, and accessibility.
  • More paperless environments.
  • Faster information exchange.
  • Increased cost savings from reduced storage space, and.
  • Reduced errors.

What is the 21 CFR part of drugs? ›

Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).

What is the meaning of in vitro diagnostic use only? ›

Overview. In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means 'in glass', meaning these tests are typically conducted in test tubes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself.

What is the CFR code for hazardous waste? ›

The F-list, found at 40 CFR section 261.31, identifies wastes from common manufacturing and industrial processes as hazardous. Because the processes generating these wastes can occur in different sectors of industry, the F list wastes are known as wastes from non-specific sources.

What is the FDA definition of in vitro diagnostics? ›

In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body.

References

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