[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR810.11]

[Page 100-101]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 810_MEDICAL DEVICE RECALL AUTHORITY--Table of Contents
 
          Subpart B_Mandatory Medical Device Recall Procedures
 
Sec. 810.11  Regulatory hearing.

    (a) 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 Sec. 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 Sec. 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 Sec. 10.19 of this chapter, including those pertaining to the 
timing of the hearing. As provided in Sec. 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.
    (b) If a request for a regulatory hearing is granted, the regulatory 
hearing shall be limited to:
    (1) Reviewing the actions required by the cease distribution and 
notification order, determining if FDA should affirm, modify, or vacate 
the order, and

[[Page 101]]

addressing an appropriate cease distribution and notification strategy; 
and
    (2) 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.
    (c) 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 Sec. 810.10, rather than a 
notice under Sec. 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 Sec. 16.80(a) of this chapter. As provided 
in Sec. 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 Sec. 10.19 of this chapter. As provided in Sec. 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.
    (d) 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.
    (e) 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 Sec. 
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 Sec. 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 Sec. 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.