D.C. Mun. Regs. tit. 22-B, § 10724
Device Master Record
Effective Jul 12, 201360 DCR 10252Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998. Source: Final Rulemaking published at 60 DCR 10252 (July 12, 2013).District of Columbia, Office of the Secretary
10724.1 Each manufacturer shall maintain device master records (DMR). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with § 10706. 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.
SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013).