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US Regulatory Aspects of Wearable Medical Devices

Wearables have experienced increasing applicability within medical device trials, yet the regulations for the use of such wearables for clinical development vary between the US and the rest of the world, and have specific requirements for medical device trials. Former FDA Director Gregory Campbell recently delivered a Cytel Webinar on the use of wearables, in clinical trials for medical devices, where he takes a careful look at what sponsors need to know.

Within a clinical research context medical device wearables can be used as a therapeutic or diagnostic device, but more and more commonly they are being used for monitoring and measurement. When properly constructed, they provide clinically meaningful measurements as both primary and secondary endpoints.

Currently only 10% of wearables device submissions use wearables as clinical data, but there are several advantages to doing so. Wearables provide unprecedented levels of data with far superior precision and accuracy than traditionally available. They are better able to monitor fluctuations in endpoints over time, enable clinicians to respond more quickly to adverse events, and offer opportunities for less expensive data collection.

Yet there are a complex series of standards of evaluation that sponsors need to understand for regulatory use. The webinar covers these in great detail.

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