10402.1 A 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.

10402.2 A 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.

10402.3 If 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.

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

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