Accurately performing and documenting design control is a crucial aspect of meeting 21 CFR Part 820 compliance requirements for medical device companies.
The FDA's mandated design control process is designed to ensure the safety and effectiveness of new medical devices that enter the marketplace, and medical device companies will have to demonstrate that they have correctly followed the process by producing a design history file and device master record that include and reference the documentation created in the design control process. Organized and timely documentation of the design control process is crucial for ensuring FDA compliance, as well as the safety and effectiveness of the medical device.
Does Your Medical Device Qualify For Design Controls?
Design control is a mandated process, but not all medical devices are required to follow the design control process. The FDA mandates that only companies building Class II and Class III devices must establish design controls, but there are some exceptions! The FDA provides the following chart of Class I devices that require design controls:
868.6810 Catheter, Tracheobronchial Suction.
878.4460 Glove, Surgeon's.
880.6760 Restraint, Protective.
892.5650 System, Applicator, Radionuclide, Manual.
892.5740 Source, Radionuclide Teletherapy
For more help classifying your medical device, check out our Step-by-Step Guide to Medical Device Classification.
Critical Path For Establishing And Documenting Design Controls
Detailed guidelines for establishing design controls can be found in 21 CFR Part 820.30.
- Design and Development Planning - Manufacturers must establish plans for design and development, and define responsibility for implementation. Design planning includes documentation of user needs that will contribute to design inputs.
- Design Inputs - Manufacturers must develop procedures to ensure that design inputs meet the requirements for the intended use of the device.
- Design Outputs - Manufacturers must define acceptance criteria to ensure that manufactured devices meet the requirements of the intended device and match the defined design inputs. We've got Design Inputs and Design Outputs down to an art form - read more here.
- Design Review - Manufacturers must create and document procedures to ensure that formal, documented reviews of the design results are conducted at appropriate times.
- Design Verification - Manufacturers must create a procedure for verifying that the design outputs meet the design input requirements.
- Design Validation - Manufacturers must test initial production lots to ensure that they meet defined user needs and intended use requirements under actual or simulated use conditions. Check out our Definitive Guide on Design Verification vs Design Validation.
- Design Transfer - Manufacturers must create a procedure to ensure that the device design can be transferred into product specifications. Read more about Best Practices for Effective Design Transfer.
- Design Changes - Manufacturers are responsible for creating and documenting procedures for identification, documentation, validation, verification, review, and approval of design changes before their implementation.
Design Controls Drive Legally Mandated Documentation Process
Design controls generate piles of documentation that must be dated and approved by the assigned party, usually a quality manager. In addition, these documents need to be organized and available for reference, review, internal and external audit and inclusion in other documents.
Each manufacturer must maintain a design history file, which references or includes all of the documents created in the design control process and shows that the design was developed in compliance with this part of the FDA's regulations.
Manufacturers must also compile a device master record, which includes all of the information needed to build and test the device. This includes drawings and documentation from the design controls, as well as production and process controls and other items.
Check out our guide on the differences between these documents and what is included in each one.