21 CFR 820.20
Management responsibility
21 CFR 820.20 is the regulation titled “Management responsibility” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 19 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
- 19 since 2021
- Jan 1 to Oct 30, 2026
- 3 against 6 on the same dates in 2025
- Most often cited with
- 21 CFR 820.198, in 17 letters
- Closed out
- 16% of these letters have a published close-out
Letters citing it, by year issued
Most are medical device letters (18 of 19). 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 820.20 most often, as written in the letters.
- 1 letterFailure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that…
- 1 letterFailure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency as required by 21 CFR 820.20(c)
- 1 letterFailure of the management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures, as…
The regulation
Read the text of 21 CFR 820.20 (eCFR, as of Jun 1, 2025)
(a) Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.
(b) Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.
(1) Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.
(2) Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.
(3) Management representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:
(i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and
(ii) Reporting on the performance of the quality system to management with executive responsibility for review.
(c) Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.
(d) Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.
(e) Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.20.
- 21 CFR 820.198Complaint files17 letters cite both
- 21 CFR 820.100Corrective and preventive action16 letters cite both
- 21 CFR 820.30Design controls16 letters cite both
- 21 CFR 807.81When a premarket notification submission is required15 letters cite both
- 21 CFR 820.22Quality audit15 letters cite both
- 21 CFR 820.50Purchasing controls14 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?10 letters cite both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance10 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.20 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 Longhorn Vaccines and Diagnostics LLCPrimeStore® MTM (Molecular Transport Medium)IssuedFeb 26, 2026PostedMar 24, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.