D.C. Mun. Regs. tit. 22, r. 22-B10614

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

Rule 22-B10614 - TEMPORARY SUSPENSION OF APPROVAL OF A PREMARKET APPROVAL APPLICATION

10614.1

This section describes the procedures that the Department will follow in exercising its authority under 21 U.S.C. § 360c(e)(3). This authority applies to the original PMA, as well as any PMA supplement(s), for a medical device.

10614.2

The Department will issue an order temporarily suspending approval of a PMA if the Department determines that there is a reasonable probability that continued distribution of the device would cause serious, adverse health consequences or death.

10614.3

If the Department believes that there is a reasonable probability that the continued distribution of a device subject to an approved PMA would cause serious, adverse health consequences or death, the Department may initiate and conduct a regulatory hearing to determine whether to issue an order temporarily suspending approval of the PMA.

10614.4

Pursuant to 21 C.F.R. part 16, the Department will initiate and conduct any regulatory hearing necessary for determining whether to issue an order temporarily supporting approval of a PMA. If the Department believes that immediate action to remove a dangerous device from the market is necessary to protect the public health, the agency may, in accordance with 21 C.F.R. § 16.60(h), waive, suspend, or modify any 21 C.F.R. part 16 procedure, pursuant to 21 CFR § 10.19.

10614.5

The Department will deem the PMA holder's failure to request a hearing within the timeframe specified by DOH in the notice of opportunity for hearing to be a waiver.

10614.6

If the PMA holder does not request a regulatory hearing or if, after the hearing, and after consideration of the administrative record of the hearing, the Department determines that there is a reasonable probability that the continued distribution of a device under an approved PMA would cause serious, adverse health consequences or death, the agency shall, under the authority of 21 U.S.C. § 360e(e)(3) of the act, issue an order to the PMA holder temporarily suspending approval of the PMA.

10614.7

Permanent withdrawal of approval of the PMA. If the Department issues an order temporarily suspending approval of a PMA, the agency shall proceed expeditiously, but within sixty (60) days, to hold a hearing on whether to permanently withdraw approval of the PMA in accordance with 21 U.S.C. § 360e(e)(1) and procedures set out in § 10613.

D.C. Mun. Regs. tit. 22, r. 22-B10614

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.