Title 21

SECTION 814.84

814.84 Reports.

§ 814.84 Reports.

(a) The holder of an approved PMA shall comply with the requirements of part 803 and with any other requirements applicable to the device by other regulations in this subchapter or by order approving the device.

(b) Unless FDA specifies otherwise, any periodic report shall:

(1) Identify changes described in § 814.39(a) and changes required to be reported to FDA under § 814.39(b).

(2) Contain a summary and bibliography of the following information not previously submitted as part of the PMA:

(i) Unpublished reports of data from any clinical investigations or nonclinical laboratory studies involving the device or related devices and known to or that reasonably should be known to the applicant.

(ii) Reports in the scientific literature concerning the device and known to or that reasonably should be known to the applicant. If, after reviewing the summary and bibliography, FDA concludes that the agency needs a copy of the unpublished or published reports, FDA will notify the applicant that copies of such reports shall be submitted.

(3) Identify changes made pursuant to an exception or alternative granted under § 801.128 or § 809.11 of this chapter.

(4) Identify each device identifier currently in use for the device, and each device identifier for the device that has been discontinued since the previous periodic report. It is not necessary to identify any device identifier discontinued prior to December 23, 2013.

[51 FR 26364, July 22, 1986, as amended at 51 FR 43344, Dec. 2, 1986; 67 FR 9587, Mar. 4, 2002; 72 FR 73602, Dec. 28, 2007; 78 FR 58822, Sept. 24, 2013]