D.C. Mun. Regs. tit. 22, r. 22-B10610
Current through Register Vol. 71, No. 49, December 6, 2024
Rule 22-B10610 - FILING A PREMARKET APPROVAL APPLICATION10610.1The filing of an application means that the Department has made a threshold determination that the application is sufficiently complete to permit a substantive review. Within forty five (45) days the Department receives a PMA, the agency will notify the applicant whether the application has been filed.
10610.2If the Department does not find that any of the reasons in § 10610.5 for refusing to file the PMA application, the agency will file the PMA and will notify the applicant in writing of the filing. The notice will include the PMA reference number and the date the Department filed the PMA. The date of filing is the date that DOH receives a PMA. The one hundred eighty (180) day period for review of a PMA starts on the date of filing.
10610.3If the Department refuses to file a PMA, the agency will notify the applicant of the reasons for the refusal. This notice will identify the deficiencies in the application that prevent filing and will include the PMA reference number.
10610.4If the Department refuses to file the PMA, the applicant may:
(a) Resubmit the PMA with additional information necessary to comply with § 10606. A resubmitted PMA shall include the PMA reference number of the original submission. If the resubmitted PMA is accepted for filing, the date of filing is the date the Department receives the resubmission; or(b) Request in writing within ten (10) working days of the date of receipt of the notice refusing to file the PMA, an informal conference with the Department to review the Department's decision not to file the PMA. The Department will hold the informal conference within ten (10) working days of its receipt of the request and will render its decision on filing within five (5) working days after the informal conference. If, after the informal conference, the Department accepts the PMA for filing, the date of filing will be the date of the decision to accept the PMA for filing. If the Department does not reverse its decision not to file the PMA, the applicant may request reconsideration of the decision from the Department. The Department's decision will constitute final administrative action for the purpose of judicial review.10610.5The Department may refuse to file a PMA if any of the following applies:
(a) The application is incomplete because it does not on its face contain all the information required;(b) The PMA does not contain each of the items required under § 10606 and justification for omission of any item is inadequate;(c) The applicant has a pending premarket notification with respect to the same device, and the Department has not determined whether the device falls within the scope of 21 C.F.R. § 814.1(c)(1)-(3);(d) The PMA contains a false statement of material fact; or(e) The PMA is not accompanied by a statement of either certification or disclosure.D.C. Mun. Regs. tit. 22, r. 22-B10610
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.