[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: 21CFR814.118]

[Page 143-144]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 814_PREMARKET APPROVAL OF MEDICAL DEVICES--Table of Contents
 
                   Subpart H_Humanitarian Use Devices
 
Sec. 814.118  Denial of approval or withdrawal of approval of an HDE.

    (a) FDA may deny approval or withdraw approval of an application if 
the

[[Page 144]]

applicant fails to meet the requirements of section 520(m) of the act or 
of this part, or of any condition of approval imposed by an IRB or by 
FDA, or any postapproval requirements imposed under Sec. 814.126. In 
addition, FDA may deny approval or withdraw approval of an application 
if, upon the basis of the information submitted in the HDE or any other 
information before the agency, FDA determines that:
    (1) There is a lack of a showing of reasonable assurance that the 
device is safe under the conditions of use prescribed, recommended, or 
suggested in the labeling thereof;
    (2) The device is ineffective under the conditions of use 
prescribed, recommended, or suggested in the labeling thereof;
    (3) The applicant has not demonstrated that there is a reasonable 
basis from which to conclude that the probable benefit to health from 
the use of the device outweighs the risk of injury or illness, taking 
into account the probable risks and benefits of currently available 
devices or alternative forms of treatment;
    (4) The application or a report submitted by or on behalf of the 
applicant contains an untrue statement of material fact, or omits 
material information;
    (5) The device's labeling does not comply with the requirements in 
part 801 or part 809 of this chapter;
    (6) A nonclinical laboratory study that is described in the HDE 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 in part 58 of this chapter 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;
    (7) Any clinical investigation involving human subjects described in 
the HDE, subject to the institutional review board regulations in part 
56 of this chapter or the informed consent regulations in part 50 of 
this chapter, was not conducted in compliance with those regulations 
such that the rights or safety of human subjects were not adequately 
protected;
    (8) The applicant does not permit an authorized FDA employee an 
opportunity to inspect at a reasonable time and in a reasonable manner 
the facilities and controls, and to have access to and to copy and 
verify all records pertinent to the application; or
    (9) The device's HUD designation should be revoked in accordance 
with Sec. 814.102(c).
    (b) If FDA issues an order denying approval of an application, the 
agency will comply with the same notice and disclosure provisions 
required for PMA's under Sec. 814.45(b) and (d), as applicable.
    (c) FDA will issue an order denying approval of an HDE after an 
approvable or not approvable letter has been sent and the applicant:
    (1) Submits a requested amendment but any ground for denying 
approval of the application under Sec. 814.118(a) still applies;
    (2) Notifies FDA in writing that the requested amendment will not be 
submitted; or
    (3) Petitions for review under section 515(d)(3) of the act by 
filing a petition in the form of a petition for reconsideration under 
Sec. 10.33 of this chapter.
    (d) Before issuing an order withdrawing approval of an HDE, FDA will 
provide the applicant with notice and an opportunity for a hearing as 
required for PMA's under Sec. 814.46(c) and (d), and will provide the 
public with notice in accordance with Sec. 814.46(e), as applicable.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998]