Title 21: Food and Drugs
PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
Subpart C—FDA Action on a PMA
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§ 814.46 Withdrawal of approval of a PMA.
(a) FDA may issue an order withdrawing approval of a PMA if, from any information available to the agency, FDA determines that:
(1) Any of the grounds under section 515(e)(1) (A)–(G) of the act applies.
(2) Any postapproval requirement imposed by the PMA approval order or by regulation has not been met.
(3) A nonclinical laboratory study that is described in the PMA 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 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.
(4) Any clinical investigation involving human subjects described in the PMA, subject to the institutional review board regulations in part 56 or informed consent regulations in part 50, was not conducted in compliance with those regulations such that the rights or safety of human subjects were not adequately protected.
(b)(1) FDA may seek advice on scientific matters from any appropriate FDA advisory committee in deciding whether to withdraw approval of a PMA.
(2) FDA may use information other than that submitted by the applicant in deciding whether to withdraw approval of a PMA.
(c) Before issuing an order withdrawing approval of a PMA, FDA will issue the holder of the approved application a notice of opportunity for an informal hearing under part 16.
(d) If the applicant does not request a hearing or if after the part 16 hearing is held the agency decides to proceed with the withdrawal, FDA will issue to the holder of the approved application an order withdrawing approval of the application. The order will be issued under §814.17, will state each ground for withdrawing approval, and will include a notice of an opportunity for administrative review under section 515(e)(2) of the act.
(e) FDA will give the public notice of an order withdrawing approval of a PMA. The notice will be published in theFederal Registerand will state that a detailed summary of information respecting the safety and effectiveness of the device, including information about any adverse effects of the device on health, has been placed on public display and that copies are available upon request. When a notice of withdrawal of approval is published, data and information in the PMA file will be available for public disclosure in accordance with §814.9.
