21 Cfr 809 (2024)

FAQs

What is 21 CFR part 809? ›

PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE.

Quality System Regulation (QS regulation) - 21 CFR Part 820

The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of 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.

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.

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).

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.

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.

A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.

Class III devices “usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.” Only 10% of medical devices marketed in the U.S. fall under this category. Examples of Class III devices include: Pacemakers. Implanted prosthetics.

Title 21 CFR, Part 11

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

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.

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.

There is a broad range of IVDs, from self-tests for pregnancy and blood glucose monitors for diabetics, to sophisticated diagnoses performed in clinical laboratories. Other examples of IVDs are HIV tests, blood type identification and cancer screening.

Pregnancy tests, COVID-19 tests, and HIV tests are examples of IVD products. Other examples of IVD devices include: Cancer diagnostics.

Top diagnostics companies based on revenue 2023

In 2023, Swiss company Roche had the highest revenue worldwide from medical diagnostics at almost 16.8 billion U.S. dollars. This was closely followed by GE Healthcare which had a revenue from diagnostics of around 16.3 billion U.S. dollars.

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.

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.

(a) You must assign qualified personnel to supervise the manufacturing, packaging, labeling, or holding of dietary supplements. (b) Each supervisor whom you use must be qualified by education, training, or experience to supervise.