Today, the U.S. Food and Drug Administration updated the Expedited Access Pathway Program website with two Data Development Plan examples that serve as a resource for sponsors.
In April 2015, the FDA issued the Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions guidance. This guidance introduced a new, voluntary program to promote the development of innovative products to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions. The EAP Program started accepting requests for EAP designation on April 15, 2015.
As part of an EAP Designation Request, sponsors should submit an acceptable draft Data Development Plan, which includes a description of the clinical and nonclinical data that the sponsor proposes to be collected both premarket and postmarket, as well as a timeline for the development and marketing of the device. The two examples added to the FDA’s website offer a format for how the Data Development Plan information recommended in the EAP guidance can be organized.
Food and Drug Administration
Center for Devices and Radiological Health