Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements

What the paper explores

This descriptive study reviewed clinical evidence supporting panel-track supplements for high-risk devices. It examined features such as randomization, blinding, comparators, endpoints and reporting of participant characteristics. The analysis highlights variation in the studies used to assess significant device modifications.

How to interpret the evidence

The findings concern historical panel-track supplements, rather than every type of device change or all supplement pathways. Study-design observations are not a device-specific regulatory determination.

Questions for MedTech teams

Define the implications of a design or indication change early. A change assessment should explain which existing evidence remains relevant and which questions need new data.