D.C. Mun. Regs. tit. 22, r. 22-B10621

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

Rule 22-B10621 - HUMANITARIAN DEVICE EXEMPTION AMENDMENTS AND RESUBMITTED HUMANITARIAN DEVICE EXEMPTIONS

10621.1

An HDE or HDE supplement may be amended or resubmitted upon an applicant's own initiative, or at the request of DOH, for the same reasons and in the same manner as prescribed for PMAs in § 10607, except that the timeframes set forth in § 10607.3(a) and § 10607.4 do not apply.

10621.2

If the Department requests an HDE applicant to submit an HDE amendment, and a written response to the Department's request is not received within seventy-five (75) days of the date of the request, the Department will consider the pending HDE or HDE supplement to be withdrawn voluntarily by the applicant. Furthermore, if the HDE applicant, on its own initiative or at the Department's request, submits a major amendment as described in § 10607.3(a), the review period may be extended up to seventy-five (75) days.

D.C. Mun. Regs. tit. 22, r. 22-B10621

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.