FDA Proposes Program to Expedite Access to High-Risk Medical Devices

FDA-Approvals-Medical-DevicesThe U.S. Food and Drug Administration is proposing a new program that would give earlier access to certain high-risk medical devices, but some are saying that the approach only benefits medical device companies. According to HealthData Management, the agency is seeking public comment on the proposal and is touting it as a “collaborative approach to facilitate product development under the agency’s existing regulatory authorities” that “seeks to reduce the time associated with product development” instead of current programs that have “focused on reducing the time for the premarket review.”

The program is called the Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions, or EAP. It attempts to incorporate lessons learned from the agency’s 2011 Innovation Pathway pilot, which sought to shorten overall time and cost of development, assessment and review of medical device.

However, critics of the program say that it would not offer significant benefits for patients. One obstacle is that the requirements to meet this program may be too narrow, since the product must address a life-threatening or irreversibly-debilitating disease. Furthermore, the product has to be much more effective than existing therapies, and many medical device companies only improve their products a little bit at a time.

If a company does qualify for the program, the FDA still has the same standards and regulations; this means that the approval process may not be faster.

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