FDA reviewers and field investigators evaluate design control requirements and processes for medical devices and make recommendations based on whether the manufacturer has the required checks and balances in place.
Design controls are a mechanism for bringing the design of certain class I and all class II and class III investigational devices under the umbrella of the good manufacturing practices (GMPs). In 1996, the GMP requirements were revised to include design control and they have become a part of the Quality System Regulations (QSR). Manufacturers must demonstrate compliance with the QSR and, as of 1996, with design control requirements.
Once the product definition and regulatory strategy have been prepared, medical device developers must work to comply with the design control provisions of the QSR as the device development process moves forward. The QSR is the medical device equivalent of the pharmaceutical current good manufacturing practices (cGMPs). The QSR, unlike cGMPs, also regulates the device development process via its design control provisions (21 CFR 820.30) which describes the device developer’s requirements under the design control provisions of the QSR.
Design controls are an integrated set of management practices (policies, processes, and procedures) which are applied to control design activities while assessing quality and correcting errors through a reiterative device process control. Once management has determined that the device is feasible and the decision has been made to transition from research to clinical applications, the design control process begins. As such, the device application becomes part of corporate quality system.
Here is a summary of key points from the full White Paper on FDA’s Design Control Requirements for Medical Devices posted on the EAS website:
- Risk and hazard analysis activities are required as part of total product life cycle (TPLC).
- The standard for the application of risk management (ISO 14971) for medical devices is part of TPLC.
- The risk management process covers risk analysis, risk evaluation, and risk controls through Corrective and Preventive Action (CAPA) plan and design control requirements.
- Design control requirements play a key role from device design prototype, manufacturing process controls and the finished device for user needs.
- The extent of testing and evaluation is proportional to the level of risks associated with the device technology and intended clinical use.
- FDA reviews the “safety and effectiveness” of the device and it is essential that any risks and hazards are mitigated to “acceptable” levels.
The full White Paper reviews medical device design, medical device quality systems and GMPs. device design control components, and FDA’s Quality System Inspection Technique (QSIT).