StacksVerified U.S. regulatory reference

21 CFR §820.181

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
Each 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:
  1. (a)Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
  2. (b)Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
  3. (c)Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
  4. (d)Packaging and labeling specifications, including methods and processes used; and
  5. (e)Installation, maintenance, and servicing procedures and methods.