Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care

Interviewed experts reported that increased use of FDA expedited approval pathways has led to greater reliance on surrogate endpoints with uncertain clinical significance and that many physicians are unaware when drugs or high‑risk devices are approved through these pathways. Participants expressed concern that evidentiary uncertainty is not adequately communicated to patients and emphasized the need to incorporate explanations of expedited review and its limitations into informed treatment consent.