The FDA requires all medical device manufacturers that design, produce and sell medical devices in the United States to follow 21 CFR 820.30. In general, the rest of the world follows ISO 13485 (7.3). As of the 2016 version of ISO 13485, for all intents and purposes, ISO 13485 (7.3) and 21 CFR 820.30 are equivalent. The following table provides a comparison between FDA and ISO 13485 requirements. The significant differences between design control regulation 21 CFR 820.30 and standard ISO 13485 (7.3) are bolded in the following column.
|21 CFR 820.30||
ISO 13485:2016 (7.3)
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.
Inputs relating to product requirements shall be determined and records maintained. These inputs shall include:
a) functional, performance, usability and safety requirements, according to the intended use;
b) applicable regulatory requirements and standards;
c) applicable output(s) of risk management;
d) as appropriate, information derived from previous similar designs;
e) Other requirements essential for design and development of the product and processes
These inputs shall be reviewed for adequacy and approved.
Requirements shall be complete, unambiguous, able to be verified or validated, and not in conflict with each other.
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.
The organization shall plan and control the design and development of product. As appropriate, the design and development planning documents shall be maintained and updated as the design and development progresses.
During design and development planning, the organization shall document:
a) the design and development stages
b) the review(s) needed at each design and development stages;
c) the verification, validation, and design transfer activities that are appropriate at each design and development stage;
d) the responsibilities and authorities for design and development;
e) the methods to ensure traceability of design and development outputs to design and development inputs
f) the resources needed, including necessary competence of personnel.
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.
The organization shall document procedures to control design and development changes. The organization shall determine the significance of the change to function, performance, usability, safety and applicable regulatory requirements for the medical device and its intended use.
Design and development changes shall be identified. Before implementation, the changes shall be:
c) validated, as appropriate
The review of the design and development changes shall include evaluation of the effects of the changes on the constituent parts of product in process or already delivered inputs or outputs of risk management and product realization process.
Records of changes, their review and any necessary actions shall be maintained.
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.
The organization shall maintain a design and development file for each medical device type or medical device family. This file shall include or reference records generated to demonstrate conformity to the requirements for design and development and records for design and development changes.
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.
Design and development output shall:
a) meet the input requirements for design and development;
b) provide appropriate information for purchasing, production and service provision;
c) contain or reference product acceptance criteria;
d) specify the characteristics of the product that are essential for its safe and proper use.
The outputs of design and development shall be in a form suitable for verification against the design and development inputs and shall be approved prior to release.
Records of the design and development outputs shall be maintained.
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).
At suitable stages, systematic reviews of design and development shall be performed in accordance with planned and documented arrangements to:
a) evaluate the ability of the results of design and development to meet requirements;
b) identify and propose necessary actions.
Participants in such reviews shall include representatives of functions concerned with the design and development stage being reviewed, as well as other specialist personnel.
Records of the results of the reviews and any necessary actions shall be maintained and include the identification of the design under review, the participants involved and the date of the review.
Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.
The organization shall document procedures for transfer of a design and development outputs to manufacturing. These procedures shall ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications and that production capability can meet product requirements. Results and conclusions of the transfer shall be recorded.
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 Design History File.
Design and development validation shall be performed in accordance with planned and documented arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use.
The organization shall document validation plans that include methods, acceptance criteria and, as appropriate, statistical techniques with rationale for sample size.
Design validation shall be conducted on representative product. Representative product includes initial production units, batches or their equivalents. The rationale for the choice product used for validation shall be recorded.
As part of design and development validation, the organization shall perform clinical evaluations or performance evaluations of the medical device in accordance with applicable regulatory requirements. A medical device used for clinical evaluation or performance evaluation is not considered to be released for use to the customer.
If the intended use requires that the medical device be connected to, or have an interface with, other medical device(s), validation shall include confirmation that the requirements for the specified application or intended use have been met when so connected or interfaced.
Validation shall be completed prior to release for use of the product to the customer.
Records of the results and conclusion of validation and necessary actions shall be maintained.
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 Design History File.
Design and development verification shall be performed in accordance with planned and documented arrangements to ensure that the design and development outputs have met the design and development input requirements.
The organization shall document verification plans that include methods, acceptance criteria and as appropriate, statistical techniques with rationale for sample size.
If the intended use requires that the medical device be connected to, or have interface with, other medical device(s), verification shall include confirmation that the design outputs meet design inputs when so connected or interfaced.
Records of the result and conclusion of the verification and necessary actions shall be maintained.