D.C. Mun. Regs. tit. 22, r. 22-B10613
Current through Register Vol. 71, No. 49, December 6, 2024
Rule 22-B10613 - WITHDRAWAL OF APPROVAL OF A PREMARKET APPROVAL APPLICATION10613.1The Department may issue an order withdrawing approval of a PMA if, from any information available to the agency, the Department determines that:
(a) Any of the grounds under 21 U.S.C. §§ 360e(e)(1) (A)-(G) applies;(b) Any post-approval requirement imposed by the PMA approval order or by regulation has not been met;(c) A nonclinical laboratory study that is described in the PMA and that is essential to show that the device is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling, was not conducted in compliance with the good laboratory practice regulations and no reason for the noncompliance is provided or, if it is, the differences between the practices used in conducting the study and the good laboratory practice regulations do not support the validity of the study; or(d) Any clinical investigation involving human subjects described in the PMA, subject to the institutional review board regulations in § 10630 or informed consent regulations, was not conducted in compliance with those regulations such that the rights or safety of human subjects were not adequately protected.10613.2The Department may seek advice on scientific matters from any appropriate Department advisory committee in deciding whether to withdraw approval of a PMA.
10613.3The Department may use information other than that submitted by the applicant in deciding whether to withdraw approval of a PMA.
10613.4Before issuing an order withdrawing approval of a PMA, the Department will issue the holder of the approved application a notice of opportunity for an informal hearing under 21 C.F.R., part 16.
10613.5If the applicant does not request a hearing or if after the hearing is held the agency decides to proceed with the withdrawal, the Department will issue to the holder of the approved application an order withdrawing approval of the application. The order will be issued under § 10604, will state each ground for withdrawing approval, and will include a notice of an opportunity for administrative review under 21 U.S.C. § 360e(e)(2).
10613.6The Department will give the public notice of an order withdrawing approval of a PMA. The notice will be published and will state that a detailed summary of information respecting the safety and effectiveness of the device, including information about any adverse effects of the device on health, has been placed on public display and that copies are available upon request. When a notice of withdrawal of approval is published, data and information in the PMA file will be available for public disclosure in accordance with § 10602.
D.C. Mun. Regs. tit. 22, r. 22-B10613
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.