21 CFR 820.198
Complaint files
21 CFR 820.198 is the regulation titled “Complaint files” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 91 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
- 91 since 2021
- Jan 1 to Oct 30, 2026
- 12 against 26 on the same dates in 2025
- Most often cited with
- 21 CFR 820.30, in 70 letters
- Closed out
- 21% of these letters have a published close-out
Letters citing it, by year issued
Most are medical device letters (90 of 91). 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 820.198 most often, as written in the letters.
- 8 lettersFailure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a)
- 3 lettersFailure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a)
- 2 lettersFailure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198
The regulation
Read the text of 21 CFR 820.198 (eCFR, as of Jun 1, 2025)
(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:
(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 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 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 § 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 unique device identifier (UDI) or universal product code (UPC), and any other 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.
[61 FR 52654, Oct. 7, 1996, as amended at 69 FR 11313, Mar. 10, 2004; 71 FR 16228, Mar. 31, 2006; 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 820.198.
- 21 CFR 820.30Design controls70 letters cite both
- 21 CFR 820.100Corrective and preventive action66 letters cite both
- 21 CFR 807.81When a premarket notification submission is required49 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?47 letters cite both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?38 letters cite both
- 21 CFR 820.50Purchasing controls34 letters cite both
- 21 CFR 803.3How does FDA define the terms used in this part?33 letters cite both
- 21 CFR 820.90Nonconforming product26 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.198 that FDA posted most recently.
- DevicesView Chirp Innovations, LLCChirp Halo Wireless Muscle StimulatorIssuedOct 2, 2026PostedOct 27, 2026
- DevicesView Peter Schiff Enterprisescardiac electrode pads and AC cardiac fibrillatorsIssuedAug 26, 2026PostedOct 27, 2026
- DevicesView Olympus Medical Systems CorporationSurgical and endotherapy devices including clips, sphincterotomes, cystoscopes, bronchoscopes, and insufflators.IssuedOct 7, 2026PostedOct 20, 2026
Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.