Section 22-B10402. GENERAL DESCRIPTION OF REPORTS REQUIRED FROM USER FACILITIES, IMPORTERS, AND MANUFACTURERS

 

10402.1A device user facility must submit the following reports:

 

(a)Reports of individual adverse events no later than ten (10) work days after the day that the facility becomes aware of a reportable event, which shall include:

 

(1) Reports of device-related deaths to the Department and to the manufacturer, if known; or

 

(2) Reports of device-related serious injuries to the manufacturers or, if the manufacturer is unknown, to the Department; and

 

(b) Annual reports described in § 10417 to the Department.

 

10402.2A device importer must submit the following reports:

 

(a)Reports of individual adverse events no later than thirty (30) calendar days after the day that the importer becomes aware of a reportable event, which shall include:

 

(1) Reports of device-related deaths or serious injuries to the Department and to the manufacturer; or

 

(2) Reports of device-related malfunctions to the manufacturer.

 

10402.3If you are a manufacturer must submit the following reports:

 

(a) Reports of individual adverse events no later than thirty (30) days after the day that you become aware of a reportable death, serious injury, or malfunction;

 

(b) Reports of individual adverse events no later than five (5) work days after the day that you become aware of:

 

(1) A reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health; or

 

(2) A reportable event for which we made a written request.

 

10402.4Supplemental reports shall be filed if information is obtained that was not submitted as part of any initial report required by this section.

 
 

 

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).