[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.181]

[Page 163]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 820_QUALITY SYSTEM REGULATION--Table of Contents
 
                            Subpart M_Records
 
Sec. 820.181  Device master record.

    Each manufacturer shall maintain device master records (DMR's). Each 
manufacturer shall ensure that each DMR is prepared and approved in 
accordance with Sec. 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.