Code of Federal Regulations Title 21. Food and Drugs § 21.820.181 Device master record

(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;

(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;

(c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;

(d) Packaging and labeling specifications, including methods and processes used;  and

(e) Installation, maintenance, and servicing procedures and methods.