[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.200]

[Page 159]
 
                        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 N_Servicing
 
Sec. 820.200  Servicing.


    (a) Where servicing is a specified requirement, each manufacturer 
shall establish and maintain instructions and procedures for performing 
and verifying that the servicing meets the specified requirements.
    (b) Each manufacturer shall analyze service reports with appropriate 
statistical methodology in accordance with Sec. 820.100.
    (c) Each manufacturer who receives a service report that represents 
an event which must be reported to FDA under part 803 of this chapter 
shall automatically consider the report a complaint and shall process it 
in accordance with the requirements of Sec. 820.198.
    (d) Service reports shall be documented and shall include:
    (1) The name of the device serviced;
    (2) Any device identification(s) and control number(s) used;
    (3) The date of service;
    (4) The individual(s) servicing the device;
    (5) The service performed; and
    (6) The test and inspection data.

[61 FR 52654, Oct. 7, 1996, as amended at 69 FR 11313, Mar. 10, 2004]