10422.1 You must submit a five (5)-day report to us no later than five (5) work days after the day that you become aware of:

(a) An MDR reportable event that necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. The manufacturer may become aware of the need for remedial action from any information, including any trend analysis; or

(b) A written request by the Department for the submission of a five (5)-day report. If you receive such a written request from the Department, you must submit, without further request, a five (5)-day report for all subsequent events of the same nature that involve substantially similar devices for the time period specified in the written request. We may extend the time period stated in the original written request if we determine it is in the interest of the public health.

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