D.C. Mun. Regs. tit. 22, r. 22-B10412

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

Rule 22-B10412 - HOW TO REPORT ADVERSE EVENTS

10412.1

If you are a user facility, you must submit MDR reports to:

(a) The manufacturer and to the Department no later than ten (10) business days after the day that you become aware of information that reasonably suggests that a device has or may have caused or contributed to a death; or

(b) The manufacturer no later than ten (10) business days after the day that you become aware of information that reasonably suggests that a device has or may have caused or contributed to a serious injury. If the manufacturer is not known, you must submit this report to the Department.

10412.2

An importer shall submit MDR reports to:

(a) The manufacturer and to the Department, no later than thirty (30) calendar days after the day that the importer becomes aware of information that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or

(b) The manufacturer, no later than thirty (30) days calendar after receiving information that a device the importer marketed has malfunctioned and that this device or a similar device that the importer marketed would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

10412.3

If you are a manufacturer, you must submit MDR reports to the Department:

(a) No later than thirty (30) calendar days after the day that you become aware of information that reasonably suggests that a device may have caused or contributed to a death or serious injury; or

(b) No later than thirty (30) calendar days after the day that you become aware of information that reasonably suggests a device 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; or

(c) Within five (5) business days if required by § 10422.

10412.4

Any information, including professional, scientific, or medical facts, observations, or opinions, may reasonably suggest that a device has caused or may have caused or contributed to an MDR reportable event. An MDR reportable event is a death, a serious injury, or, if you are a manufacturer or importer, a malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

10412.5

If you are a user facility, importer, or manufacturer, you do not have to report an adverse event if you have information that would lead a person who is qualified to make a medical judgment reasonably to conclude that a device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur. Persons qualified to make a medical judgment include physicians, nurses, risk managers, and biomedical engineers. You must keep in your MDR event files the information that the qualified person used to determine whether or not a device-related event was reportable.

D.C. Mun. Regs. tit. 22, r. 22-B10412

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.