FDA approval



April 22, 2014

Washington routinely comes in for criticism that it doesn’t do enough to support the U.S. medical device industry. But a new FDA proposal would establish for medical devices the equivalent of its breakthrough therapy program for pharma. The proposal would give devices serving a critical need a faster path to market.

It has proposed a program that would encourage more interaction at earlier stages of product development between companies and the regulator’s staff.

The pithy proposal is called Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions. It would involve a collaboratively developed plan for collecting the scientific and clinical data to support approval.

Here’s some of the criteria. Medical devices would need to:

  • Treat or diagnose a life-threatening or irreversibly debilitating disease or condition
  • Address lack of approved alternative treatment/diagnostic exits
  • Be a breakthrough technology that provides a clinically meaningful advantage over existing technology
  • Be a technology where its availability is in the patient’s best interest
  • Have an acceptable data development plan that has been approved by the FDA

Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said that the regulator expected most devices that enter this program will be in the pre-clinical trial phase, according to a statement.

The medical device program is the latest to come out of the Innovation Pathway pilot which got started in 2011. The FDA developed a couple of expedited review programs for pharmaceuticals, including Accelerated Approval and Breakthrough Therapies.

The regulator is accepting public comment on the proposal through July.

Read more: http://medcitynews.com/2014/04/fda-medical-device-proposal-would-develop-faster-path-to-market-for-some-devices/#ixzz2zxAQXDkD


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