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# FDA Updates Expedited Access Pathway Web Site
- URL: https://www.fdaweb.com/fda-updates-expedited-access-pathway-web-site/
- Published: 2016-09-28T12:00:00.000Z
- Updated: 2026-09-14T21:35:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136934

FDA says it has updated the Expedited Access Pathway (EAP) Program Web [site](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/ucm441467.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) with two Data Development Plan examples that are a resource for sponsors. The agency released 4/2015 a guidance that introduced that new voluntary program to promote development of innovative products to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions.

As part of an EAP designation request, sponsors should submit an acceptable draft Data Development Plan that includes descriptions of the clinical and non-clinical data that the sponsor proposes to be collected both pre-market and post-market, as well as a timeline for development and marketing of the device. CDRH says that the two examples added to the Web site give a format for organizing the Data Development Plan information recommended in the EAP guidance.