Align your evidence plan with risk analysis: map each risk to verification, validation, or clinical data. Propose special controls tied to risks, ensure GCP compliance, and use a PreSub to confirm FDA expectations before submission.
Your evidence strategy should mirror your risk analysis. For each identified risk, align a corresponding verification or validation activity and demonstrate that the residual risk is acceptable. Low-risk and well-mitigated devices may rely primarily on robust bench testing, while others require clinical data to establish safety and effectiveness.
When clinical studies are used, the FDA expects investigations to be compliant with Good Clinical Practice (GCP) and to maintain data integrity. The FDA’s Acceptance of Clinical Data guidance clarifies expectations regarding data quality, monitoring, ethics, and applicability.
Don’t treat special controls as an afterthought. Propose controls that directly address the risks to health and the performance characteristics that matter. For Class II devices, special controls supplement general controls and are enforceable by the FDA.
Study existing Class II special controls for analogous risk patterns to inform your proposals.
Use a PreSub meeting to confirm whether your bench and clinical data package is appropriately sized. Discuss whether real-world evidence, human factors engineering/usability (HFE/UE), or postmarket commitments are expected by FDA.
