D.C. Mun. Regs. tit. 22, r. 22-B10420

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10420 - INDIVIDUAL ADVERSE EVENT REPORTS REQUIREMENTS FOR MANUFACTURERS

10420.1

A manufacturer shall report to the Department no later than thirty (30) calendar days after the day that it receives or otherwise becomes aware of information, from any source, that reasonably suggests that a device that it markets:

(a) May have caused or contributed to a death or serious injury; or

(b) Has malfunctioned and the device or a similar device that it markets would likely cause or contribute to a death or serious injury, if the malfunction were to recur.

10420.2

The manufacturer shall submit all information required that is reasonably known to it. The following information is considered to be reasonably known:

(a) Any information that can be obtained by contacting a user facility, importer, or other initial reporter;

(b) Any information in the manufacturer's possession; or

(c) Any information that the manufacturer can obtain by analysis, testing, or other evaluation of the device.

10420.3

The manufacturer is responsible for obtaining and submitting to the Department information that is incomplete or missing from reports submitted by user facilities, importers, and other initial reporters.

10420.4

The manufacturer is also responsible for investigating each event and evaluating the cause of the event. If the manufacturer cannot submit complete information in a report, it shall provide a statement explaining why this information is incomplete and the steps it took to obtain the information. If the manufacturer later obtains any required information that was not available at the time it filed the initial report, it shall submit this information in a supplemental report.

D.C. Mun. Regs. tit. 22, r. 22-B10420

Final Rulemaking published at 60 DCR 10252 (July 12, 2013)

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.