Section 22-B10626. PROCEDURES FOR REVIEW OF A HUMANITARIAN DEVICE EXEMPTION

 

10626.1The Department will begin substantive review of an HDE after the HDE is accepted for filing under § 10624. The Department may refer an original HDE application to a panel on its own initiative, and shall do so upon the request of an applicant, unless the Department determines that the application substantially duplicates information previously reviewed by a panel. If the HDE is referred to a panel, the agency shall follow the procedures set forth under § 10611, with the exception that the Department will complete its review of the HDE and the advisory committee report and recommendations within seventy-five (75) days from receipt of an HDE that is accepted for filing under § 10624 or the date of filing as determined under § 10621, whichever is later.  Within the later of these two timeframes, the Department will issue an approval order under § 10626.2, an approvable letter under § 10626.3, a not approvable letter under § 10626.4, or an order denying approval of the application under § 10627.1.

 

10626.2The Department will issue to the applicant an order approving an HDE if none of the reasons in § 10627 for denying approval of the application applies. The Department will approve an application on the basis of draft final labeling if the only deficiencies in the application concern editorial or similar minor efficiencies in the draft final labeling. Such approval will be conditioned upon the applicant incorporating the specified labeling changes exactly as directed and upon the applicant submitting to the Department a copy of the final printed labeling before marketing. The notice of approval of an HDE will be published by the Department in accordance with the rules and policies applicable to PMAs submitted under § 10606. Following the issuance of an approval order, data and information in the HDE file will be available for public disclosure in accordance with § 10602.2 through § 10602.10, as applicable.

 

10626.3The Department will send the applicant an approvable letter if the application substantially meets the requirements of this section and the agency believes it can approve the application if specific additional information is submitted or specific conditions are agreed to by the applicant. The approvable letter will describe the information the Department requires to be provided by the applicant or the conditions the applicant is required to meet in order to obtain approval. For example, the Department may require as a condition to approval:

 

(a) The submission of certain information identified in the approvable letter (such as, final labeling);

 

(b) Restrictions imposed on the device under 21 U.S.C. § 360j(e);

 

(c) Post-approval requirements; and

 

(d) A Department inspection that finds the manufacturing facilities, methods, and controls in compliance with Chapter 106 and, if applicable, that verifies records pertinent to the HDE.

 

10626.4The Department will send the applicant a not approvable letter if the agency believes that the application may not be approved for one (1) or more of the reasons given in § 10627. The not approvable letter will describe the deficiencies in the application and, where practical, will identify measures required to place the HDE in approvable form. The applicant may respond to the not approvable letter in the same manner as permitted for not approvable letters for PMAs under § 10611.9, with the exception that if a major HDE amendment is submitted, the review period may be extended up to seventy-five (75) days.

 

10626.5The Department will consider an HDE to have been withdrawn voluntarily if:
 

(a)The applicant fails to respond in writing to a written request for an amendment within seventy-five (75) days after the date DOH issues such request;
 

(b)The applicant fails to respond in writing to an approvable or not approvable letter within seventy-five (75) days after the date the Department issues such letter; or

 

(c)The applicant submits a written notice to the Department that the HDE has been withdrawn.

 

 

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).