Section 22-B10728. SERVICING

 

10728.1Where servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements.

 

10728.2Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with § 10716.

 

10728.3Each manufacturer who receives a service report that represents an event which must be reported to the Department under Chapter 104 shall automatically consider the report a complaint and shall process it in accordance with the requirements of § 10728.

 

10728.4Service reports shall be documented and shall include:

 

(a) The name of the device serviced;

 

(b) Any device identification(s) and control number(s) used;

 

(c) The date of service;

 

(d) The individual(s) servicing the device;

 

(e) The service performed; and

 

(f)The test and inspection data.

 

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).