§ 820.198 Complaint files. ( a ) Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that: ( 1 ) All complaints are processed in a uniform and timely manner;
( 2 ) Oral complaints are documented upon receipt; and
( 3 ) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting.
( b ) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.
( c ) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.
( d ) Any complaint that represents an event which must be reported to FDA under part 803 of this chapter shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or otherwise clearly identified. In addition to the information required by § 820.198(e), records of investigation under this paragraph shall include a determination of: ( 1 ) Whether the device failed to meet specifications;
( 2 ) Whether the device was being used for treatment or diagnosis; and
( 3 ) The relationship, if any, of the device to the reported incident or adverse event.
( e ) When an investigation is made under this section, a record of the investigation shall be maintained by the formally designated unit identified in paragraph (a) of this section. The record of investigation shall include: ( 1 ) The name of the device;
( 2 ) The date the complaint was received;
( 3 ) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used;
( 4 ) The name, address, and phone number of the complainant;
( 5 ) The nature and details of the complaint;
( 6 ) The dates and results of the investigation;
( 7 ) Any corrective action taken; and
( 8 ) Any reply to the complainant.
( f ) When the manufacturer's formally designated complaint unit is located at a site separate from the manufacturing establishment, the investigated complaint(s) and the record(s) of investigation shall be reasonably accessible to the manufacturing establishment.
( g ) If a manufacturer's formally designated complaint unit is located outside of the United States, records required by this section shall be reasonably accessible in the United States at either: ( 1 ) A location in the United States where the manufacturer's records are regularly kept; or
( 2 ) The location of the initial distributor.
[61 FR 52654, Oct. 7, 1996, as amended at 69 FR 11313, Mar. 10, 2004; 71 FR 16228, Mar. 31, 2006; 78 FR 58822, Sept. 24, 2013]