ARTICLE SUMMARY:
A focus on Q3 guidance documents delving into expectations for medtech clinical data and study designs.
Questions over appropriate clinical data expectations and study designs and procedures are a constant source of deliberation for device and diagnostic developers. In designing meaningful studies, devices, whether of the physical or digital variety, raise unique challenges compared to pharmaceuticals, and there can be divergence about what type and volume of studies might be needed in specific cases and whether clinical data is necessary in the first place.
Europe, in particular, right now is struggling with transparency and clarity around clinical data requirements, as explored recently by Market Pathways.
But all jurisdictions must be vigilant on this topic, and, unsurprisingly, clinical requirements are a frequent topic of guidelines, standards, and rules issued by medtech policymakers and regulators around the world. In this edition of Docs of the Month, we spotlight some noteworthy recent releases—all from the third quarter of 2024—intended to help the sector better understand the what, when, and how for clinical data.
