21 Cfr 809 (2025)

FAQs

What is 21 CFR 809? ›

PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE.

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.

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.

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.

(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.

On May 6, 2024, the FDA issued a final rule amending the FDA's regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory.

When additives are included, the IV solution container must be labeled with the name, strength, amount of all additives, diluents, date prepared, and a revised expiration date.

Among the claims that can be used on food and dietary supplement labels are three categories of claims that are defined by statute and/or FDA regulations: health claims, nutrient content claims, and structure/function claims.

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.

Who must comply with 21 CFR Part 11? ›

21 CFR Part 11 states that electronic records and electronic signatures are treated the same as paper records and handwritten signatures. Regulated companies with any documents or records in electronic format must comply with the regulation.

(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.

CFR stands for “Code of Federal Regulation.” 21 CFR Part 11, in particular, details the criteria under which electronic records and signatures are considered to be trustworthy and equivalent to paper records.

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.

A 21 CFR Part 11 compliant system ensures the integrity of electronic records, reducing the risk of data tampering, loss, or unauthorized modifications. This promotes accurate and reliable data throughout the record lifecycle.

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).

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.

eCFR :: 40 CFR 261.3 -- Definition of hazardous waste.

809.3 Definitions. (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.