D.C. Mun. Regs. tit. 22, r. 22-B10607

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10607 - PREMARKET APPROVAL APPLICATION AMENDMENTS AND RESUBMITTED PREMARKET APPROVAL APPLICATION

10607.1

An applicant may amend a pending PMA or PMA supplement to revise existing information or provide additional information.

10607.2

The Department may request the applicant to amend a PMA or PMA supplement with any information regarding the device that is necessary for the Department or the appropriate advisory committee to complete the review of the PMA or PMA supplement.

10607.3

A PMA amendment submitted to DOH shall include the PMA or PMA supplement number assigned to the original submission and, if submitted on the applicant's own initiative, the reason for submitting the amendment. The Department may extend the time required for its review of the PMA, or PMA supplement, as follows:

(a) If the applicant on its own initiative or at the Department's request submits a major PMA amendment (for example, an amendment that contains significant new data from a previously unreported study, significant updated data from a previously reported study, detailed new analyses of previously submitted data, or significant required information previously omitted), the review period may be extended up to one hundred eighty (180) days; or

(b) If an applicant declines to submit a major amendment that the Department requests, the review period may be extended for the number of days that elapse between the date of such request and the date that DOH receives the written response declining to submit the requested amendment.

10607.4

An applicant may on its own initiative withdraw a PMA or PMA supplement. If the Department requests an applicant to submit a PMA amendment and a written response to the Department's request is not received within one hundred eighty (180) days of the date of the request, the Department will consider the pending PMA or PMA supplement to be withdrawn voluntarily by the applicant.

10607.5

An applicant may resubmit a PMA or PMA supplement after withdrawing it or after it is considered withdrawn under § 10607.4, or after the Department has refused to accept it for filing, or has denied approval of the PMA or PMA supplement. A resubmitted PMA or PMA supplement shall comply with the requirements of § 10606 or § 10608, respectively, and shall include the PMA number assigned to the original submission and the applicant's reasons for resubmission of the PMA or PMA supplement.

D.C. Mun. Regs. tit. 22, r. 22-B10607

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.