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 -- In Vitro Diagnostic Products for Human Use - eCFR 4. 21 CFR Part 809 | US Law | LII / Legal Information Institute 5. In vitro diagnostic - CFR - Code of Federal Regulations Title 21 - FDA 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 8. 21 CFR § 809.3 - Definitions. - Law.Cornell.Edu 9. FDA's Final Rule on Laboratory-Developed Tests 10. 21 CFR 809 In Vitro Diagnostic Products for Human Use with TOC 11. Medical Devices; Laboratory Developed Tests - Federal Register 12. IVDs – A Comparison of Requirements between the US and ... 13. Food and Drug Administration Regulation of in Vitro Diagnostic ... 14. PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE 15. 0910-AI85 - View Rule 16. Part 809. In Vitro Diagnostic Products For Human Use - Subchapter ... - vLex FAQs References

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.”

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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

  • Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.

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4. 21 CFR Part 809 | US Law | LII / Legal Information Institute

21 CFR Part 809 | US Law | LII / Legal Information Institute
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5. 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."

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6. [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 ...

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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

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8. 21 CFR § 809.3 - Definitions. - Law.Cornell.Edu

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

  • § 809.3 Definitions.

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21 CFR § 809.3 - Definitions. - Law.Cornell.Edu
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9. FDA's Final Rule on Laboratory-Developed Tests

  • 8 mei 2024 · The US Food and Drug Administration's highly anticipated final rule on laboratory-developed tests was officially published in the Federal Register on Monday, ...

  • 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
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10. 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.

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11. Medical Devices; Laboratory Developed Tests - Federal Register

  • 6 mei 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
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12. IVDs – A Comparison of Requirements between the US and ...

  • IVDs also have specific labeling requirements under 21 CFR 809 that must be complied with, prior to marketing or obtaining marketing authorization.

  • Get insights on the differences and similarities in IVD requirements between the US and EU markets.

IVDs – A Comparison of Requirements between the US and ...
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13. Food and Drug Administration Regulation of in Vitro Diagnostic ...

  • 2 nov 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 ...

Food and Drug Administration Regulation of in Vitro Diagnostic ...
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14. PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

  • Statutes, codes, and regulations · Code of Federal Regulations. •••. Title 21 - FOOD AND DRUGS CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH ...

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

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15. 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.

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16. Part 809. In Vitro Diagnostic Products For Human Use - Subchapter ... - vLex

  • Part 809. In Vitro Diagnostic Products For Human Use [Details]. Subpart ... Code of Federal Regulations · 2021 Edition · Title 21. Food and Drugs · Chapter I ...

  • Part 809. In Vitro Diagnostic Products For Human Use [Details]. Subpart A. General Provisions. Subpart B. Labeling. Subpart C. Requirements For

Part 809. In Vitro Diagnostic Products For Human Use - Subchapter ... - vLex
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21 Cfr 809 (2024)

FAQs

What is 21 CFR 809? ›

PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE.

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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.

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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.

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What is the FDA definition of in vitro diagnostic device? ›

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

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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.

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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.

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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.

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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.

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

EU Annex 11 addresses computerized systems used in GMP-regulated activities, providing appropriate implementation and management guidelines. While 21 CFR Part 11 specifically targets electronic records and signatures, EU Annex 11 takes a broader approach by encompassing the whole computerized system.

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Who does 21 CFR apply to? ›

Practically speaking, Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions.

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What is the summary of 21 CFR? ›

21 CFR regulations generally apply to manufacturers of medical devices, pharmaceuticals, or nutraceuticals. These companies produce healthcare and wellness products such as insulin pumps, medications like ibuprofen, or nutritional supplements like vitamins.

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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.

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What is the difference between IVD and medical devices? ›

A medical device is an in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use.

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What is an example of an IVD medical device? ›

Other examples of IVDs are HIV tests, blood type identification and cancer screening. Unlike medical devices or pharmaceuticals, IVDs never come into contact with a person. IVDs do not treat patients, but provide information about the functioning of the body.

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What is the FDA approval for a medical device? ›

A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.

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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).

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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.

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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.

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What is the CFR 21 drug storage? ›

All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF).

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