21 CFR 820.200: Servicing

Required manufacturers, where servicing is a specified requirement, to establish procedures for performing and verifying service, statistically analyze service reports, treat reportable-event service reports as complaints, and document service details including device identity, date, servicer, work

Part 820, Quality System Regulation · Subpart N, Servicing

Most device 483s cite the Quality System Regulation in force before February 2, 2026, when the QMSR replaced it. Those sections are marked Former.

How FDA words it

The opening lines investigators use most when they cite 820.200, from the 483s we hold.

Procedures or instructions for performing servicing activities and verifying that servicing meets specified requirements have not been adequately established.Most used

Service reports do not include the required information.820.200(d)

Procedures or instructions for performing servicing activities have not been adequately established.820.200(a)

Cited over time

483s citing 820.200, by year

Most citations in 2022. Bars are relative to the busiest year. *2026 to date.

Recent 483s citing 820.200

See all 483s citing 820.200

The regulation text

§ 820.200 Servicing. As published before it was replaced.

(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 unique device identifier (UDI) or universal product code (UPC), and any other 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; 78 FR 58822, Sept. 24, 2013]

Questions

What does 21 CFR 820.200 require?

How do FDA investigators word a 820.200 observation?

The most common opening is: “Procedures or instructions for performing servicing activities and verifying that servicing meets specified requirements have not been adequately established.”

Which sections are cited alongside 820.200?

In the same 483s, investigators most often also cite 820.198 (Complaint files), 820.100 (Corrective and preventive action), 820.30 (Design controls), 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?).