Section 22-B10724. DEVICE MASTER RECORD

 

10724.1Each 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.

 

authority

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).