Section 22-B10611. PROCEDURES FOR REVIEW OF A PREMARKET APPROVAL APPLICATION

 

10611.1The Department will begin substantive review of a PMA after the PMA is accepted for filing under § 10610. The Department may refer the PMA to a panel on its own initiative, and will do so upon request of an applicant, unless the Department determines that the application substantially duplicates information previously reviewed by a panel. If the Department refers an application to a panel, the Department will forward the PMA, or relevant portions thereof, to each member of the appropriate Department panel for review. During the review process, the Department may communicate with the applicant as set forth under 21 C.F.R. § 814.37(b), or with a panel to respond to questions that may be posed by panel members or to provide additional information to the panel. The Department shall maintain a record of all communications with the applicant and with the panel.

 

10611.2The advisory committee shall submit a report to the Department which includes the committee's recommendation and the basis for such recommendation on the PMA. Before submission of this report, the committee shall hold a public meeting to review the PMA. This meeting may be held by a telephone conference under 21 C.F.R. § 14.22(g). The advisory committee report and recommendation may be in the form of a meeting transcript signed by the chairperson of the committee.
 

10611.3The Department will complete its review of the PMA and the advisory committee report and recommendation and, within the later of one hundred eighty (180) days from the date of filing of the PMA under 21 C.F.R. § 814.42 or the number of days after the date of filing as determined under 21 C.F.R. § 814.37(c)(1)-(2), issue an approval order under 21 C.F.R. § 814.44(d), an approvable letter under 21 C.F.R. § 814.44(e), a not approvable letter under 21 C.F.R. § 814.44(f), or an order denying approval of the application under 21 C.F.R. § 814.45(a)(1)-(5).
 

10611.4The Department will issue to the applicant an order approving a PMA if none of the reasons in 21 C.F.R. § 814.45(a) 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 deficiencies 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 Department will also give the public notice of the order, including notice of and opportunity for any interested persons to request review under 21 U.S.C. § 360e(d)(3).

 

10611.5The notice of approval will be placed on the Department's website and it will state that a detailed summary of information respecting the safety and effectiveness of the device, which was the basis for the order approving the PMA, including information about any adverse effects of the device on health, is available on the Internet and has been placed on public display, and that copies are available upon request. The Department will publish after each quarter a list of the approvals announced in that quarter. When a notice of approval is published, data and information in the PMA file will be available for public disclosure in accordance with § 10602.

 

10611.6A request for copies of the current PMA approvals and denials document and for copies of summaries of safety and effectiveness shall be sent in writing to the Department.
 

10611.7The 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.

 

10611.8The approvable letter will describe the information the Department requires to be provided by the applicant or the conditions the applicant is required to meet 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 (for example, final labeling);

 

(b) A Department inspection that finds the manufacturing facilities, methods, and controls in compliance with Chapter 107 and, if applicable, that verifies records pertinent to the PMA;

 

(c) Restrictions imposed on the device; or

 

(d) Post-approval requirements as described in 21 C.F.R. § 814.80, et seq.

 

10611.9In response to an approvable letter the applicant may:

 

(a) Amend the PMA as requested in the approvable letter;

 

(b) Consider the approvable letter to be a denial of approval of the PMA under § 10612 and request administrative review under 21 U.S.C. § 360e(d)(3) by filing a petition in the form of a petition for reconsideration; or

 

(c) Withdraw the PMA.

 

10611.10The Department will send the applicant a not approvable letter if the agency believes that the application may not be approved for one or more of the reasons given in 21 C.F.R. § 814.45(a)(1)-(5). The not approvable letter will describe the deficiencies in the application, including each applicable ground for denial, and, where practical, will identify measures required to place the PMA in approvable form. In response to a not approvable letter, the applicant may:

 

(a) Amend the PMA as requested in the not approvable letter (such an amendment will be considered a major amendment under 21 C.F.R. § 814.37(c)(1)-(2); or

 

(b) Consider the not approvable letter to be a denial of approval of the PMA under § 10612 and request administrative review by filing a petition in the form of a petition for reconsideration; or

 

(c) Withdraw the PMA.

 

10611.11DOH will consider a PMA to have been withdrawn voluntarily if:

 

(a) The applicant fails to respond in writing to a written request for an amendment within one hundred eighty (180) days after the date the Department issues such request;

 

(b) The applicant fails to respond in writing to an approvable or not approvable letter within one hundred eighty (180) days after the date the Department issues such letter; or

 

(c)The applicant submits a written notice to the Department that the PMA 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).