CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 820—QUALITY SYSTEM REGULATION > SUBPART N—Servicing (§820.200 to §820.200) > 820.200—Servicing.

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 § 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 § 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.

Code of Federal Regulations

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