Source: http://www.law.cornell.edu/cfr/text/21/814.45
Timestamp: 2013-12-13 01:32:30
Document Index: 728846369

Matched Legal Cases: ['art 814', '§ 814', 'art 801', 'art 809', 'art 56', 'art 50', '§ 814', '§ 860', '§ 814', '§ 10']

21 CFR 814.45 - Denial of approval of a PMA. | Title 21 - Food and Drugs | Code of Federal Regulations | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter H › Part 814 › Subpart C › Section 814.45	prev | next
21 CFR 814.45 - Denial of approval of a PMA.
§ 814.45
(a) FDA may issue an order denying approval of a PMA if the applicant fails to follow the requirements of this part or if, upon the basis of the information submitted in the PMA or any other information before the agency, FDA determines that any of the grounds for denying approval of a PMA specified in section 515(d)(2) (A) -(E) of the act applies. In addition, FDA may deny approval of a PMA for any of the following reasons:
(2) The device's proposed labeling does not comply with the requirements in part 801 or part 809 ;
(5) 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) FDA will issue any order denying approval of the PMA in accordance with § 814.17. The order will inform the applicant of the deficiencies in the PMA, including each applicable ground for denial under section 515(d)(2) of the act and the regulations under this part, and, where practical, will identify measures required to place the PMA in approvable form. The order will include a notice of an opportunity to request review under section 515(d)(4) of the act.
(c) FDA will use the criteria specified in § 860.7 to determine the safety and effectiveness of a device in deciding whether to approve or deny approval of a PMA. FDA may use information other than that submitted by the applicant in making such determination.
(d) (1) FDA will give the public notice of an order denying approval of the PMA. The notice will be placed on the FDA's home page on the Internet (http://www.fda.gov ), and it 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, is available on the Internet and has been placed on public display and that copies are available upon request. FDA will publish in the Federal Register after each quarter a list of the denials announced in that quarter. When a notice of denial of approval is made publicly available, data and information in the PMA file will be available for public disclosure in accordance with § 814.9.
(2) A request for copies of the current PMA approvals and denials document and copies of summaries of safety and effectiveness shall be sent in writing to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
(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 § 10.33.
[51 FR 26364, July 22, 1986, as amended at 63 FR 4572, Jan. 30, 1998; 73 FR 34859, June 19, 2008; 76 FR 31470, June 1, 2011]