The DHR and DMR
Design History File (DHF): This is a collection of records that describe the design history of a medical device. The FDA specifies requirements for the DHF in Title 21 CFR section 820.30 as follows.
Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.
Device Master Record (DMR): The DMR is comprised of drawings, instructions, and other records used to produce a product. According to FDA Title 21 CFR section 820.181, manufacturers shall ensure that each DMR is prepared and approved in accordance with 820.40:
The DMR shall include, or refer to the location of, the following information:
- Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
- Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
- Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
- Packaging and labeling specifications, including methods and processes used; and
- Installation, maintenance, and servicing procedures and methods.