Wednesday, February 17, 2010

Devices Appropriate for Expedited FDA Regulatory Review

FDA considers a device or combination product containing a device appropriate for expedited regulatory review if the device or combination product:
  1. is intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and
  2. addresses an unmet medical need, as demonstrated by one of the following:
  • the device represents a breakthrough technology that provides a clinically meaningful advantage over existing technology
  • no approved alternative treatment or means of diagnosis exists
  • the device offers significant, clinically meaningful advantages over existing approved alternative treatments
  • the availability of the device is in the best interest of patients.

Under "special " considerations, pharma manufacturers who are working with a Federal Agency in the development of medical devices to address a national security issue should include a letter in the premarket regulatory submission from the Federal Agency, likely, Department of Defense, Department of Homeland Defense, identifying the specific device or device type and indicating that commercial availability is of particular importance to our national security. The letter of course, must be printed on official agency letterhead and signed by an individual with appropriate authority for making the request.

More information to come pertaining to the definition of "breakthrough", "clinically significant therapeutic advantages" and "public health benefit on device availability".

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