[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.198]

[Page 149-150]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 820--QUALITY SYSTEM REGULATION--Table of Contents
 
                           Subpart M--Records
 
Sec. 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:

[[Page 150]]

    (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 or 804 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 or 804 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 
Sec. 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 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.