D.C. Mun. Regs. tit. 22, r. 22-B10407

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

Rule 22-B10407 - REQUESTS FOR ADDITIONAL INFORMATION

10407.1

The Department will notify you in writing if we require additional information and will tell you what information we need. The Department will require additional information if the Department determines that protection of the public health requires additional or clarifying information for medical device reports submitted to the Department and in cases when the additional information is beyond the scope of the Department's reporting forms or is not readily accessible to the Department.

10407.2

In any request under this section, the Department will state the reason or purpose for the information request, specify the due date for submitting the information, and clearly identify the reported event(s) related to our request. The Department shall confirm in writing any requests for additional information that it makes verbally.

D.C. Mun. Regs. tit. 22, r. 22-B10407

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.