Any request for a regulatory hearing shall be submitted in writing to the agency employee identified in the order within the timeframe specified by FDA. Under § 16.22(b) of this chapter, this timeframe ordinarily will not be fewer than 3 working days after receipt of the cease distribution and notification order. However, as provided in § 16.60(h) of this chapter, the Commissioner of Food and Drugs or presiding officer may waive, suspend, or modify any provision of part 16 under § 10.19 of this chapter, including those pertaining to the timing of the hearing. As provided in § 16.26(a), the Commissioner or presiding officer may deny a request for a hearing, in whole or in part, if he or she determines that no genuine and substantial issue of fact is raised by the material submitted in the request.

If a request for a regulatory hearing is granted, the regulatory hearing shall be limited to:

Reviewing the actions required by the cease distribution and notification order, determining if FDA should affirm, modify, or vacate the order, and addressing an appropriate cease distribution and notification strategy; and

Determining whether FDA should amend the cease distribution and notification order to require a recall of the device that was the subject of the order. The hearing may also address the actions that might be required by a recall order, including an appropriate recall strategy, if FDA later orders a recall.

If a request by the person named in a cease distribution and notification order for a regulatory hearing is granted, the regulatory hearing will be conducted in accordance with the procedures set out in section 201(x) of the act (21 U.S.C. 321(x)) and part 16 of this chapter, except that the order issued under § 810.10, rather than a notice under § 16.22(a) of this chapter, provides the notice of opportunity for a hearing and is part of the administrative record of the regulatory hearing under § 16.80(a) of this chapter. As provided in § 16.60(h) of this chapter, the Commissioner of Food and Drugs or presiding officer may waive, suspend, or modify any provision of part 16 under § 10.19 of this chapter. As provided in § 16.26(b), after the hearing commences, the presiding officer may issue a summary decision on any issue if the presiding officer determines that there is no genuine and substantial issue of fact respecting that issue.

If the person named in the cease distribution and notification order does not request a regulatory hearing within the timeframe specified by FDA in the cease distribution and notification order, that person will be deemed to have waived his or her right to request a hearing.

The presiding officer will ordinarily hold any regulatory hearing requested under paragraph (a) of this section no fewer than 2 working days after receipt of the request for a hearing, under § 16.24(e) of this chapter, and no later than 10 working days after the date of issuance of the cease distribution and notification order. However, FDA and the person named in the order may agree to a later date or the presiding officer may determine that the hearing should be held in fewer than 2 days. Moreover, as provided for in § 16.60(h) of this chapter, the Commissioner of Food and Drugs or presiding officer may waive, suspend, or modify any provision of part 16 under § 10.19 of this chapter, including those pertaining to the timing of the hearing. After the presiding officer prepares a written report of the hearing and the agency issues a final decision based on the report, the presiding officer shall provide the requestor written notification of the final decision to affirm, modify, or vacate the order or to amend the order to require a recall of the device within 15 working days of conducting a regulatory hearing.