U.S. Food and Drug Administration

Today, the U.S. Food and Drug Administration released two final guidance documents that will facilitate timely access to important new technology without compromising FDA’s high standards for safety and effectiveness. 

The first guidance document, Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval (downloadable below), clarifies FDA’s current policy on balancing premarket and postmarket data collection during FDA review of premarket approval applications (PMAs).

The second guidance document, Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions (downloadable below), introduces a new, voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions and are subject to premarket approval applications (PMAs) or de novo requests. 

The Expedited Access Pathway Program (EAP) will start accepting requests for EAP designation on April 15, 2015. 

Additional information about the EAP program can be found at Expedited Access Pathway Program http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/ucm441467.htm  .

Together, these guidance documents may help bring qualifying devices to patients with life-threatening or irreversibly debilitating conditions. 

An informational webinar will be scheduled for later this spring.

Download “Balancing Premarket and Postmarket Data Collection for Devices” UCM393994.pdf – Downloaded 179 times – 426 B

Download “Expedited Access for Premarket Approval and De Novo Medical Devices” UCM393978.pdf – Downloaded 181 times – 426 B

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Safety Assessment in Clinical Trials and Beyond

FDA’s Two Final Guidances Facilitating Timely Access to Important New Technology