Section 22-B10624. FILING A HUMANITARIAN DEVICE EXEMPTION

 

10624.1The filing of an HDE means that the Department has made a threshold determination that the application is sufficiently complete to permit substantive review. Within thirty (30) days from the date an HDE is received by the Department, the agency will notify the applicant whether the application has been filed. The Department may refuse to file an HDE if any of the following applies:
 

(a) The application is incomplete because it does not on its face contain all the information required under § 10620.2;

 

(b) The Department determines that there is a comparable device available (other than another HUD approved under this section or a device under an approved IDE) to treat or diagnose the disease or condition for which approval of the HUD is being sought;

 

(c) The application contains an untrue statement of material fact or omits material information; or

 

(d) The HDE is not accompanied by a statement of either certification or disclosure, or both, as required by 21 C.F.R., part 54.

 

10624.2The provisions contained in §§ 10610.2, 10610.3, and 10610.4 regarding notification of filing decisions, filing dates, the start of the seventy-five (75) day review period, and applicant's options in response to the Department’s refusal to file decisions shall apply to HDEs.

 

 

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.

source

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