Medical devices are ubiquitous — from thermometers, bandages, and dental floss to blood glucose meters, hearing aids, and complex implantable devices such as pacemakers. The latest cutting-edge examples even extend to apps on tablets and PCs that physicians use to help monitor and treat patients. Before a medical device can be put on the market,…
Expertise: MedTech 31 results
Significant risk studies of medical devices require an investigational device exemption (IDE), which allows the device to be used in a clinical study to collect data on its safety and effectiveness.1 Often, device developers wonder whether—and how—the cost of those investigational devices might be covered not only to offset the cost of development, but also…
An investigational device exemption (IDE) allows an investigational device to be used in a clinical study to collect data on its safety and effectiveness.1 This exemption applies to the conduct of trials necessary for developing new medical devices. Most often, clinical studies are conducted to support a Premarket Approval (PMA) application, though some 510(k) submissions…
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Will Bainbridge
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Nicole Sativtsky
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Suzanne Courtney
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