21 CFR 820.186
Quality system record
21 CFR 820.186 is the regulation titled “Quality system record” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 3 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
- 3 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 803.17, in 2 letters
- Closed out
- 33% 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.
The regulation
Read the text of 21 CFR 820.186 (eCFR, as of Jun 1, 2025)
Each manufacturer shall maintain a quality system record (QSR). The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s), including, but not limited to, the records required by § 820.20. Each manufacturer shall ensure that the QSR is prepared and approved in accordance with § 820.40.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.186.
- 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 820.100Corrective and preventive action2 letters cite both
- 21 CFR 820.160Distribution2 letters cite both
- 21 CFR 820.181Device master record2 letters cite both
- 21 CFR 820.184Device history record2 letters cite both
- 21 CFR 820.198Complaint files2 letters cite both
- 21 CFR 820.20Management responsibility2 letters cite both
- 21 CFR 820.25Personnel2 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.186 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 W.H.P.M, Inc.COVID-19 Test KitsIssuedJun 30, 2022PostedJul 12, 2022
- DevicesView Tianjin Bolang Science-Technology Development Co., Ltd.Otoscopes, Rigid Laryngoscopes, and Rigid NasopharyngoscopesIssuedJun 17, 2021PostedAug 17, 2021
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Counts include every citation in a letter, as the Letters filter does. How this database is built.