Section 22-B10418. INDIVIDUAL ADVERSE EVENT REPORTING REQUIREMENTS FOR IMPORTERS

 

10418.1When reporting deaths or serious injuries, an importer shall submit a report to the Department, and a copy of this report to the manufacturer, as soon as practicable but no later than thirty (30) calendar days after the day that the importer receives or otherwise becomes aware of information from any source, including user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that one (1) of the importer’s marketed devices may have caused or contributed to a death or serious injury.

 

10418.2When reporting malfunctions, an importer shall submit a report to the manufacturer as soon as practicable but no later than thirty (30) calendar days after the day that you receive or otherwise become aware of information from any source, including user facilities, individuals, or through the importer’s own research, testing, evaluation, servicing, or maintenance of one of the importer’s devices, that reasonably suggests that one (1) of the devices has malfunctioned and that this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

 

 

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).