Title 21 CFR Part 11 of the Code of Federal Regulations deals with the FDA guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

The current Good Manufacturing Practices (GMP) requirements set forth in the Quality System (QS) regulation require that domestic (US) or foreign manufacturers have a quality system for the design and production of medical devices intended for commercial distribution in the United States.