D.C. Municipal Regulations (Last Updated: September 13, 2017) |
Title 22. HEALTH |
SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
Chapter 22-B106. PREMARKET APPROVAL OF MEDICAL DEVICES |
Section 22-B10614. TEMPORARY SUSPENSION OF APPROVAL OF A PREMARKET APPROVAL APPLICATION
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10614.1This 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.
10614.2The 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.
10614.3If 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.
10614.4Pursuant 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.
10614.5The 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.
10614.6If 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.