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.
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.
Detailed guidelines for establishing design controls can be found in 21 CFR Part 820.30.
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.