The Code of Federal Regulations (CFR) is a listing of administrative laws, published in the Federal Register by the various agencies of the US Government. These rules are divided into 50 titles. Title 21 covers all food and drug requirements. This title is then broken into three chapters: Chapter I pertains to the FDA, Chapter II the Drug Enforcement Administration, and Chapter III the Office of National Drug Control Policy.
Each of these Chapters is divided into subchapters, and the 800 series of Chapter I is directly related to medical devices. For the manufacture of biological indicators, we comply with 21 CFR Part 820. This Part provides guidance for setting policies, procedures and objectives to promote the production of quality products. Included in this section are the standards for purchasing controls, how to handle non-conforming material, corrective and preventive action (CAPA), inspection of components/product, process validation, calibration of equipment, along with production controls. The purpose of these requirements is to ensure that a company produces a consistent, safe, effective product.
Companies that are required to comply with Part 820 include suppliers to medical device manufacturers, producers of the finished medical device, and distributors of the final product.