21 CFR 820.30
Design controls
21 CFR 820.30 is the regulation titled “Design controls” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 112 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
- 112 since 2021
- Jan 1 to Oct 30, 2026
- 16 against 27 on the same dates in 2025
- Most often cited with
- 21 CFR 820.100, in 80 letters
- Closed out
- 20% of these letters have a published close-out
Letters citing it, by year issued
Most are medical device letters (110 of 112). 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 820.30 most often, as written in the letters.
- 3 lettersFailure to establish and maintain adequate procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)
- 2 lettersFailure to adequately establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example:
- 2 lettersFailure to establish and maintain procedures for validating the device design, including risk analysis, as required by 21 CFR 820.30(g)
The regulation
Read the text of 21 CFR 820.30 (eCFR, as of Jun 1, 2025)
(a) General. (1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
(2) The following class I devices are subject to design controls:
(i) Devices automated with computer software; and
(ii) The devices listed in the following chart.
(b) Design and development planning. Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.
(c) Design input. Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.
(d) Design output. Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented.
(e) Design review. Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).
(f) Design verification. Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.
(g) Design validation. Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.
(h) Design transfer. Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.
(i) Design changes. Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.
(j) Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.30.
- 21 CFR 820.100Corrective and preventive action80 letters cite both
- 21 CFR 820.198Complaint files70 letters cite both
- 21 CFR 807.81When a premarket notification submission is required51 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?43 letters cite both
- 21 CFR 820.50Purchasing controls40 letters cite both
- 21 CFR 820.75Process validation37 letters cite both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?35 letters cite both
- 21 CFR 803.3How does FDA define the terms used in this part?31 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.30 that FDA posted most recently.
- DevicesView Next Medical Products Company, LLCClear Image Ultrasound Gel, Clear Image Sterile, non-sterile MediChoice Ultrasound Gel, and Clear Image SinglesIssuedAug 19, 2026PostedNov 3, 2026
- 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
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