21 Cfr 809 (2025)

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

§ 809.20 - 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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2. 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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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.

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

[CITE: 21CFR809]. TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H - MEDICAL DEVICES. PART ...
(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) ...
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21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h, 360i, 360j, 371, 372, 374, 381.

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

Sep 29, 2023 · We anticipate that applying the same oversight approach to laboratories and non-laboratories that manufacture IVDs would better assure the ...

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

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

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8. 21 CFR Subpart B - Subpart B—Labeling - Law.Cornell.Edu

Title 21—Food and Drugs · CHAPTER I—FOOD AND ... PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE; Subpart B—Labeling. 21 CFR Subpart B - Subpart B—Labeling.
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9. 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
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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. [PDF] Draft Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD ...

Oct 25, 2007 · 21 CFR Part 809, In Vitro Diagnostic Products for Human Use, found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm ...

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12. Medical Devices; Laboratory Developed Tests - Federal Register

May 6, 2024 · IVDs are also subject to specific labeling requirements in part 809 of the regulations (21 CFR part 809). For additional discussion of how ...
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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13. Am I Complying with FDA Medical Device Labeling Requirements?

Apr 4, 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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14. 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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15. Fair Debt Collection Practices Act | Federal Trade Commission

§809. Validation of debts §810. Multiple debts §811. Legal actions by debt collectors §812. Furnishing certain deceptive forms §813. Civil liability §814 ...
Fair Debt Collection Practices Act As amended by Public Law 111-203, title X, 124 Stat.

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16. FDA on General Principles of Labeling for Medical Devices - RegDesk

Jul 19, 2021 · In general, the applicable requirements are described in the following regulations: 21 CFR Part 801 – General Device labeling;; 21 CFR Part 809 ...
The core principles of the regulatory approach for labeling for medical devices are described in a guidance document issued by the FDA.

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17. 21 CFR § 809.40 Restrictions on the sale, distribution, and use of OTC ...

Title 21. SECTION 809.40. CFR; ›; Title 21; ›; Volume 8; ›; Chapter I; ›; Subchapter H; ›; Part 809 ›; Subpart C ›; Section 809.40 ...
CFR Title 21 Section 809.40 Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing of the Electronic Code of Federal Regulations

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18. Executive Office for Immigration Review | Virtual Law Library

809 (BIA 2024)(PDF); Matter of M-N-I-, 28 I&N Dec. 803 (BIA 2024)(PDF ... Cast 21, 19 OCAHO no. 1571a (2024)(PDF); US Tech Workers v. Sharma Strategy ...

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FAQs

What is 21 CFR part 809? ›

PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE.

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How to increase compliance to 21 CFR Part 11? ›

Below are just a few examples of ways advanced tools are making 21 CFR Part 11 compliance easier for today's quality and manufacturing professionals.

Inspection-Ready Electronic Records. ...
Automated Audit Trail Capture. ...
Reliable Electronic Signatures. ...
Comprehensive User Authentication and Authorization Enforcement.

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What are the requirements for labeling the immediate container of IVDs? ›

The following information must be included in the labeling on the immediate container of the IVD:

The established and proprietary names of the product, e.g., glucose meters;
A statement of warnings or precautions for users listed in 16 CFR part 1500 (hazardous substances) and any other warnings.

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What needs to be 21 CFR Part 11 compliant? ›

(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

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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 vitro diagnostic? ›

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 21 CFR Part 11 risk? ›

Additionally, 21 CFR Part 11 requires that companies have clear auditing and security protocols in place, critical components of a security risk management program program, as well as procedures that make sure that the data is used correctly. Industries that must comply with 21 CFR Part 11 include: Pharmaceuticals.

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Is Docusign 21 CFR Part 11 compliant? ›

The Docusign Part 11 module helps customers meet their legal and regulatory obligations, including the Food and Drug Administration (FDA) 21 CFR Part 11 regulation (Part 11).

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What is the benefit of 21 CFR Part 11? ›

21 CFR Part 11 provides an opportunity for medical device companies to reap the organizational benefits of paperless record-keeping systems. It also helps the FDA ensure that when medical device companies use electronic record-keeping systems, that document security and authenticity are adequately maintained.

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Do all containers have to be labeled? ›

The hazard warning labeling requirement is only enforced and limited to the actual container holding the hazardous substance, i.e. bottle, tube, can, jar, etc. There is no OSHA requirement for hazardous warning labels on the outer shipping container.]"

What is the difference between MDR and IVD? ›

While the MDR requires a continuous post-market clinical follow-up of the medical device, the IVDR requires post-market surveillance and vigilance of the IVD device. In addition, the two regulations require some different post-market surveillance deliverables to ensure a fully compliant PMS system.

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What 3 things must be listed on a chemical transfer container label? ›

All hazardous chemicals shipped after June 1, 2015, must be labeled with specified elements including pictograms, signal words and hazard and precautionary statements.

What are 21 CFR Part 11 checklists? ›

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 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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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.

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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 CFR covers medical devices? ›

eCFR :: 21 CFR Chapter I Subchapter H -- Medical Devices.

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What does CFR Title 21 cover? ›

The Code of Federal Regulations Title 21 contains the codified Federal laws and regulations that are in effect as of the date of the publication pertaining to food and drugs, both legal pharmaceuticals and illegal drugs.

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What is the 21 CFR Part 820? ›

This part establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged.

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