Section 22-B10612. DENIAL OF APPROVAL OF A PREMARKET APPROVAL APPLICATION

 

10612.1The Department may issue an order denying approval of a PMA if the applicant fails to follow the requirements of this section or if, upon the basis of the information submitted in the PMA or any other information before the agency, the Department determines that any of the grounds for denying approval of a PMA specified in 21 U.S.C. §§ 360e(d)(2)(A)-(E) of the act, apply. In addition, the Department may deny approval of a PMA for any of the following reasons:
 

(a) The PMA contains a false statement of material fact;

 

(b) The device's proposed labeling does not comply with the requirements in Chapter 103 of this subtitle;

 

(c) The applicant does not permit an authorized Department employee an opportunity to inspect at a reasonable time and in a reasonable manner the facilities, controls, and to have access to and to copy and verify all records pertinent to the application;

 

(d)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
 

(e)Any clinical investigation involving human subjects described in the PMA, subject to the institutional review board regulations 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.

 

10612.2The Department will issue any order denying approval of the PMA in accordance with § 10604. The order will inform the applicant of the deficiencies in the PMA, including each applicable ground for denial under 21 U.S.C. § 360e(d)(2) and the regulations under this section, and, where practical, will identify measures required to place the PMA in approvable form. The order will include a notice of an opportunity to request review under 21 U.S.C. § 360e(d)(4).

 

10612.3The Department will determine the safety and effectiveness of a device in deciding whether to approve or deny approval of a PMA. DOH may use information other than that submitted by the applicant in making such determination.
 

10612.4The Department will give the public notice of an order denying approval of the PMA.  The notice 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, including information about any adverse effects of the device on health, is available on the website 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 denials announced in that quarter. When a notice of denial of approval is made publicly available, data and information in the PMA file will be available for public disclosure under § 10602.

 

10612.5A request for copies of the current PMA approvals and denials document and copies of summaries of safety and effectiveness shall be sent in writing to the Department.
 

10612.6The Department will issue an order denying approval of a PMA after an approvable or not approvable letter has been sent and the applicant:

 

(a) Submits a requested amendment but any ground for denying approval of the application under 21 U.S.C. § 360e(d)(2) still applies; or

 

(b) Notifies the Department in writing that the requested amendment will not be submitted; or

 

(c)Files a petitions for reconsideration under 21 U.S.C. § 360e (d)(3).

 

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).