21 CFR 820.200
Servicing
21 CFR 820.200 is the regulation titled “Servicing” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 4 FDA warning letters have cited it.
Part 820 changed when FDA's Quality Management System Regulation took effect on February 2, 2026. This is the earlier text these letters cite.
- Letters citing it
- 4 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 3 on the same dates in 2025
- Most often cited with
- 21 CFR 820.198, in 3 letters
- Closed out
- 25% of these letters have a published close-out
Letters citing it, by year issued
All are medical device letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 820.200 most often, as written in the letters.
- 2 lettersFailure to adequately establish procedures for performing servicing activities and verifying that servicing meets specified requirements, as required by 21 CFR 820.200(a)
- 1 letterFailure to establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements, as required by 21 CFR 820.200
The regulation
Read the text of 21 CFR 820.200 (eCFR, as of Jun 1, 2025)
(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]
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.200.
- 21 CFR 820.198Complaint files3 letters cite both
- 21 CFR 820.30Design controls3 letters cite both
- 21 CFR 820.75Process validation3 letters cite both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance3 letters cite both
- 21 CFR 820.90Nonconforming product3 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?2 letters cite both
- 21 CFR 807.81When a premarket notification submission is required2 letters cite both
- 21 CFR 820.100Corrective and preventive action2 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.200 that FDA posted most recently.
- DevicesView LEVO AGLEVO C3; LEVO Combi; LEVO LAE; and LEVO LCEV, Class II Standup WheelchairsIssuedJul 18, 2025PostedOct 21, 2025
- DevicesView Uscom KftSpirometers including SpiroThor, Spirosonic, SpiroSonic AIR, SpiroSonic FLO, and SpiroSonic SMARTIssuedJul 30, 2025PostedAug 26, 2025
- DevicesView Mectronic Medicale S.R.L.Therapeutic RF, laser, and laser/cryotherapy devicesIssuedJun 27, 2025PostedAug 5, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.