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FDA Releases PMA Expedited Access, Premarket & Postmarket Data Collection Guidance

Wednesday, April 23, 2014  
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The Food and Drug Administration (FDA) released two guidance documents this week; one outlining an expedited access program for medical devices and another addressing collection of data in the postmarket setting to support device approvals. Comments on both sets of draft guidance should be submitted within 90 days of publication which would be Tuesday, July 22, 2014

 

In releasing guidance entitled, "Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Disease or Conditions," FDA outlines a proposal for 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 (PMA). The new program is being called the Expedited Access PMA (EAP) program. Further information on the EAP program can be found by clicking here.

 

In releasing guidance entitled, "Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval," FDA attempts to clarify current policy on balancing premarket and postmarket data collection during the Agency's review of premarket approval applications (PMAs). To view this guidance document in its entirety, please click here.