21 CFR § 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 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 § 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 § 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 § 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 § 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)(4) of the act by filing a petition in the form of a petition for reconsideration under § 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 § 814.46(c) and (d), and will provide the public with notice in accordance with § 814.46(e), as applicable.