D.C. Mun. Regs. tit. 22, r. 22-B10422

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

Rule 22-B10422 - FIVE (5) - DAY REPORTS FOR MANUFACTURERS

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.

D.C. Mun. Regs. tit. 22, r. 22-B10422

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.