§ 804.35 - Files.

(a) A device distributor shall establish a device complaint file in accordance with § 820.198 of this chapter and maintain a record of any information, including any written or oral communication, received by the distributor concerning all events that were considered for possible reporting under this part. Device incident records shall be prominently identified as such and shall be filed by device. The file shall also contain a copy of any MDR along with any additional information submitted to FDA under this part. A distributor shall maintain records that document the submission of copies of MDR's to manufacturers.

(b) A device distributor shall retain copies of the records required to be maintained under this section for a period of 2 years from the date that the report or additional information is submitted to FDA under § 804.25, or for a period of time equivalent to the design and expected life of the device, whichever is greater, even if the distributor has ceased to distribute the device that is the subject of the report or the additional information.

(c) A device distributor shall maintain the device complaint files established under this section at the distributor's principal business establishment. A distributor that is also a manufacturer may maintain the file at the same location as the manufacturer maintains its complaint file under §§ 820.180 and 820.198 of this chapter. A device distributor shall permit any authorized FDA employee, during all reasonable times, to have access to, and to copy and verify, the records required by this part.