All medical device manufacturers supplying medical devices to the U.S. are required to maintain a quality management system in compliance with the Code of Federal Regulations (CFR) Title 21, otherwise known as 21 CFR 820. The quality management system requirements cover a broad range of areas, including production and process controls, corrective and preventive actions, product development and management.
21 CFR 820 Requirements
Manufacturers of medical device supplying to the U.S. are subject to inspection of their quality management systems for compliance with the requirements of 21 CFR 820. As a rule, this takes four working days and encompasses management, development, corrective and preventive action, as well as production and process control.
Manufacturers have to be prepared for the handling of FDA inspections, to prevent issues during the four days audits.