10624. FILING A HUMANITARIAN DEVICE EXEMPTION

10624 FILING A HUMANITARIAN DEVICE EXEMPTION 10624.1 The 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: The application is incomplete because it does not on its face contain all the information required under § 10620.2; 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; The application contains an untrue statement of material fact or omits material information; or The HDE is not accompanied by a statement of either certification or disclosure, or both, as required by 21 C.F.R., part 54. 10624.2 The 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. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10624