In a recent blog post, Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health ("CDRH"), discussed a voluntary program by which sponsors of devices that treat life-threatening or irreversibly debilitating conditions may now request Expedited Access Program ("EAP") designation for premarket submissions. The blog post discusses a Data Development Plan, which will shift certain premarket requirements to the postmarket setting. In addition, for EAP-designated devices, FDA may be willing to accept more uncertainty if balanced by other factors, such as the benefits of having earlier access to the device. FDA published two guidance documents on the subject, one outlining the EAP and the other on balancing premarket and postmarket data collection.
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