21 CFR 820.30 Design Control

Design Control is one of the most important quality elements of medical device quality system. Table below tabulate each element of design control(1,2). I just copied verbatim directly from the FDA website.

Since the brevity of the blog post, it is impractical to discuss every element in detail. But,
when initiating a medical device, follow and comply with all elements of design control. The keys are having a plan, write procedures for everything and documents every activities in detail about the medical device. Have all the protocols and reports of all testing filed and organized in one location. Always keep the Design History File (DHF) most updated.

Basically, Design Controls are an interrelated set of practices and procedures that are incorporated into the design and development process (2).

Subpart C: 21 CFR 820.30 Design Control(1)
820.30 Design Controls (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
21 CFR 820.30 Design Control (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.
21 CFR 820.30 Design Control (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.
21 CFR 820.30 Design Control (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.
21 CFR 820.30 Design Control (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).
21 CFR 820.30 Design Control (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.
21 CFR 820.30 Design Control (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.
21 CFR 820.30 Design Control (h)Design transfer.	Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.
21 CFR 820.30 Design Control (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.
21 CFR 820.30 Design Control (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.

 

1.     –21 CFR-Code of Federal Regulation Title 21, www.fda.gov, page last updated: 06/01/2013.

2.     –Design Control Guidance For Medical Device Manufacturers, March 11 1997, FDA

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.