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.”

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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. 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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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.

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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 ...

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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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.

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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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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.

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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...

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14. 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 ...
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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, ...

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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

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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? ›

IVDD Labeling Requirements

It should contain clearly written step-by-step directions for use, with illustrations and drawings where appropriate, ensuring the user has a clear understanding of how to interpret certain results, including false positives or false negatives.

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What are the 21 CFR guidelines in pharma? ›

Compliance with the 21 CFR guidelines for pharma requires efficient management of disparate GMP functions to ensure drug products meet the requirements for safety, quality, strength, 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.

How to be 21 CFR Part 11 compliant? ›

7 Tips for FDA 21 CFR Part 11 Compliance

Know how to use computer systems and software, particularly when it isn't working properly.
Maintain data safely and securely, and ensure data is not corrupted or lost.
Ensure that approval and review signatures cannot be disputed.
Trace changes to data.

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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.

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.

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Which parts of 21 CFR deal with drugs? ›

eCFR Content

Subchapter A	General	1 – 99
Subchapter B	Food for Human Consumption	100 – 199
Subchapter C	Drugs: General	200 – 299
Subchapter D	Drugs for Human Use	300 – 499
Subchapter E	Animal Drugs, Feeds, and Related Products	500 – 599

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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.

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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 Part 11 conformance for medical devices? ›

It's Part 11 of Title 21 of the Code of Federal Regulations, of course. Put simply, Part 11 sets out how a life science company operating in the US can establish an FDA-compliant, digital Quality Management System using electronic records and e-signatures in place of paper-based documentation and 'wet signatures'.

What CFR covers 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 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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