Faster Review for Specific Devices

FDA just released a draft document proposing that a new “Expedited Access Program” (EAP) be established to handle unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications. FDA believes that the EAP will help patients have more timely access to these medical devices by expediting their development, assessment, and review. 

To be eligible for EAP Designation, the three EAP criteria are:

  • The device is needed to treat or diagnose a life-threatening or irreversibly debilitating disease or condition
  • The device represents a breakthrough technology that provides a clinically meaningful advantage over existing technology and no approved alternative treatment or means of diagnosis exists
  • The sponsor submits an acceptable draft Data Development Plan

 

The draft Data Development Plan needs to describe the clinical and nonclinical data that would be collected both premarket and postmarket. The premarket data must be adequate to support a determination that there is reasonable assurance of safety and effectiveness.

If the sponsor proposes collecting certain data in the postmarket setting rather than premarket, the draft plan should provide the rationale for postmarket data collection and contain valid clinical or nonclinical scientific evidence. The draft Data Development Plan should also include a timeline for the development and marketing of the device as well as for the postmarket data collection.

Comments on FDA’s draft guidance can be submitted anytime, however, the comments need to be submitted before FDA begins to work on the final version of guidance and FDA would like to see the submissions by July 22, 2014.

For more information, go to www.fda.gov, click on Medical devices or go to the April 23, 2014 Federal Register.

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