FDA 21 CFR 820 Briefly Explained

The Food and Drug Administration (FDA) is responsible for regulating all the methods and facility controls used in and for all finished products and devices intended for human use. This includes design, manufacturing, packaging, labeling, installing, storage and servicing. That is a lot of complicated information to devise, regulate, inform and educate manufacturers, retailers and consumers about. It is done using good practices to develop a number of codes of federal regulations (CFR) for foods, cosmetics, pharmacies, devices, etc. These codes pertain to specific aspects of the FDA’s duties. For example, fda 21 cfr 820 refers to the specific code that regulated medical devices. Code number 820 establishes the basic requirements applicable to manufacturers of completed medical devices and is intended to ensure that the finished devices will be safe, effective and comply with all regulations.

Although each code is specific, the guidelines for all codes include some common general principles which are as follows:

  • Hygiene is addressed as it pertains to workers, robotics and machinery.
  • Controlled environment conditions are indicated to prevent cross contamination situations.
  • Manufacturing processes are clearly defined and controlled.
  • Instructions are included in all codes, as are training requirements for systems operators.
  • Documentation and records regulations are clear as they apply to the code.
  • Complaints are examined, so there are requirements regarding grievances and the procedures to process and track those.

Educating appropriate businesses and employees of the regulations which dictate their end product is important, and must be done clearly and concisely to be effective. The FDA has complied their codes and regulations into printable handbooks, posters and brochures to make sure information is readily available. Some are written for professionals, designers, and businesses while others are aimed at the general public. This material can be single focused, as with the brochures, or it can be mixed and matched into handbooks that include as many codes as apply to your business or profession or manufactured product. You can compile the appropriate information for your needs yourself, or you can order copies of the information for clients, patients in a waiting room, perspective employees, and possible business partners.