21 CFR 820.30 is a regulation that outlines the requirements for design controls for medical devices in the United States. The regulation applies to all medical device manufacturers who sell products in the US market.
The purpose of 21 CFR 820.30 is to ensure that medical devices are designed and developed with a focus on safety, effectiveness, and quality. The regulation requires manufacturers to establish and maintain a design control process that is appropriate for the specific device being developed.
The requirements of 21 CFR 820.30 include the establishment of a design and development plan, which outlines the design inputs, design outputs, and design reviews that will be used in the development process. The regulation also requires manufacturers to establish design input requirements that are based on the needs of the end-user and the intended use of the device.
Additionally, 21 CFR 820.30 requires manufacturers to document design verification and validation activities, which are used to demonstrate that the device meets its design input requirements and is safe and effective for its intended use. The regulation also requires manufacturers to establish design changes procedures, which are used to manage changes to the device design and ensure that changes are properly documented and validated.
Another requirement of 21 CFR 820.30 is the establishment of a design history file (DHF), which is a comprehensive record of the device design and development process. The DHF must contain all design inputs, outputs, verification and validation activities, and design changes.
Overall, compliance with 21 CFR 820.30 is critical for medical device manufacturers who want to sell their products in the US market. By establishing and maintaining a robust design control process, manufacturers can ensure that their devices are safe, effective, and meet regulatory requirements.