Section 820.181 - [Effective until 2/2/2026] Device master recordEach manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with § 820.40 . The DMR for each type of device shall include, or refer to the location of, the following information:
(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.