21 Cfr 809 (2024)

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 ...

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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 ...

  • Enhanced content is provided to the user to provide additional context.

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

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

5. 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."

6. 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 ...

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

  • 21 CFR 809 - In-Vitro Diagnostic Products. 10Part809-1.jpg 1-933734-46-9. US FDA Title 21 CFR Parts. Part 809 - In Vitro Diagnostic Products for Human Use ...

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

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

9. 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.

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 ...

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

11. 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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12. 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.

13. 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...

Medical Devices; Laboratory Developed Tests - Federal Register

14. 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

15. [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, ...

16. 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.

In Vitro Diagnostic Device Labeling Requirements - FDA
21 Cfr 809 (2024)

FAQs

What is 21 CFR part 809? ›

PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE.

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 is the 21 CFR Part 11 validation protocol? ›

What is 21 CFR Part 11? 21 CFR Part 11 outlines the federal requirements that help to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

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 does CFR Title 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 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.

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 are the three primary areas of 21 CFR Part 11? ›

The 21 CFR Part 11 establishes requirements to ensure data integrity, security, and reliability in electronic records and signatures to achieve its aim.

Who does 21 CFR apply to? ›

Title 21 CFR, Part 11

Generally speaking, part 11 applies to medical device manufacturers, drug makers, biotech companies, and other FDA-regulated industries.

What are the benefits of 21 CFR Part 11? ›

21 CFR Part 11 ensures that any data stored or exchanged electronically is secure, accurate, and reliable. It also requires companies to adhere to certain standards of data security.

What does CFR stand for? ›

The Code of Federal Regulations (CFR) is a codification (arrangement of) the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. eCFR Updated Daily (ACFR-endorsed)

What is 21 CFR Part 11 simplified? ›

What Are the Requirements of 21 CFR Part 11? The 21 CFR Part 11 requirements outline criteria for electronic records, electronic signatures, and handwritten signatures on electronic records to be considered trustworthy, reliable, and comparable to paper records and signatures on paper.

What are 21 CFR Part 11 checklist? ›

The 21 CFR Part 11 compliance checklist is a tool that can be used to evaluate the level of compliance with the requirements outlined in 21 CFR Part 11. It provides a comprehensive list of questions to consider when assessing the compliance of electronic records and electronic signature systems.

What is FDA's main concern in regards to 21 CFR Part 11? ›

21 CFR Part 11 is the FDA's regulation for electronic documentation and electronic signatures. It outlines the administration of electronic records in a medical device company's quality management system and gives guidance for industry best practices.

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 are the system requirements for 21 CFR Part 11? ›

What Are the Requirements of 21 CFR Part 11? The 21 CFR Part 11 requirements outline criteria for electronic records, electronic signatures, and handwritten signatures on electronic records to be considered trustworthy, reliable, and comparable to paper records and signatures on paper.

What is the equivalent of 21 CFR Part 11? ›

Global Equivalents to 21 CFR Part 11

Annex 11 offers a guide to operating in a compliant GXP space, while Part 11 is a list of prohibitions, but they are largely harmonized. Notable differences include how individuals must be identified and expectations regarding personal liability for use or misuse of secure access.

What is a medical device according to the FDA? ›

Definition of a Medical Device. Section 201(h) of the Food, Drug & Cosmetic Act. (FD&C Act) defines a device as: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar.

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