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. CFR - Code of Federal Regulations Title 21 - FDA 7. 21 CFR 809 - In-Vitro Diagnostic Products - GMP Publications 8. [PDF] Food and Drug Administration 21 CFR Part 809 [Docket No. FDA-2023-N ... 9. 21 CFR § 809.4 - Confidentiality of submitted information. 10. 21 CFR 809 In Vitro Diagnostic Products for Human Use with TOC 11. 809.30 - CFR - Code of Federal Regulations Title 21 - FDA 12. PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE 13. 809.11 - CFR - Code of Federal Regulations Title 21 - FDA 14. [PDF] Draft Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD ... 15. Am I Complying with FDA Medical Device Labeling Requirements? 16. In Vitro Diagnostic Device Labeling Requirements - FDA FAQs References

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.”

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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 ...

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4. 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

  • (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."

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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

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

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9. 21 CFR § 809.4 - Confidentiality of submitted information.

  • CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES · SUBCHAPTER H—MEDICAL DEVICES · PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN ...

  • § 809.4 Confidentiality of submitted information.

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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. 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.

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12. 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

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13. 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.

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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, ...

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15. 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.

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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.

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21 Cfr 809 (2024)

FAQs

What is 21 CFR part 809? ›

PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE.

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What are the labeling requirements for IVDD? ›

3 Labelling information for IVDDs as required by Section 21(2) The information must be presented in a legible, prominent, and permanent (at a minimum the lifetime of the device) manner. The label information must be presented in a format most likely to be understood by the intended user.

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What are the 21 CFR guidelines in pharma? ›

21 CFR Parts 210 and 211 Regulations

Subpart F, Section 211.100 – There shall be written procedures for production and process control, assuring that drug products have the intended identity, strength, quality, and purity.

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What does for in-vitro diagnostic use mean on a pregnancy test? ›

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. In vitro tests may be done in laboratories, health care facilities or even in the home.

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How do I become 21 CFR Part 11 compliant? ›

7 Tips for FDA 21 CFR Part 11 Compliance
  1. Know how to use computer systems and software, particularly when it isn't working properly.
  2. Maintain data safely and securely, and ensure data is not corrupted or lost.
  3. Ensure that approval and review signatures cannot be disputed.
  4. Trace changes to data.
May 12, 2023

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How to use an in-vitro diagnostic test? ›

In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person's overall health to help cure, treat, or prevent diseases.

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What are the restrictions for IVDD? ›

Recovery from IVDD surgery requires 6 - 8 weeks of restricted activity. Running, climbing stairs, playing with other dogs, or jumping on furniture need to be prevented in order to avoid further damage as your dog's spine heals.

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What are the classification rules for IVDD? ›

IVDDs are grouped into the following four risk classes based on the degree of risk associated with the use of an IVDD. An IVDD with the highest risk is classified as Class IV while an IVDD associated with the lowest risk is classified as Class I.

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What does 1 copy of IVDD mean? ›

Type 1 IVDD is a degenerative condition of the intervertebral discs, which are the cushion-like structures that exist between the vertebrae in the spine. It is referred to as "1 copy" to indicate a specific genetic predisposition that increases the risk of developing this condition in certain breeds of dogs.

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Who does 21 CFR apply to? ›

Coverage. 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 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.

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What is the CFR rule? ›

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. It is divided into 50 titles that represent broad areas subject to Federal regulation.

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Why does my pregnancy test say for in vitro use only? ›

This has nothing to do with IVF/In-vitro fertilization. These can test pregnancies that come from IVF *or* IUI or regular natural pregnancies. The words "in vitro" have to do with how you use the strips (outside your body) not how you got pregnant.

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Is vitro testing accurate? ›

In vitro testing reliably delivers information about the safety and efficacy of cosmetic formulas and can be tailored to suit a specific product's needs. Compared to animal studies, in vitro testing offers such advantages as higher speed and greater accuracy, with added ethical benefits.

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

21 CFR Part 11 outlines requirements for using electronic records and signatures in lieu of traditional paper-based methods. It establishes guidelines for managing, retaining, and authenticating electronic records to ensure their accuracy, reliability, and confidentiality.

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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.

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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.

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