FDA proposes accelerated medical device approval plan

April 23, 2014
FDA proposes accelerated medical device approval plan

(HealthDay)—The U.S. Food and Drug Administration has proposed a new program that would provide expedited access to high-risk medical devices intended for patients with serious conditions whose medical needs are not met by current technology.

The proposed Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions ("Expedited Access PMA" or "EAP") program features earlier and more interactive engagement with staff from the FDA. This will include the involvement of senior management and a collaboratively developed plan for collecting the data to support approval.

According to the FDA, EAP is not a new pathway to market, but rather an approach where all parties work together to facilitate product development under the agency's existing regulatory authorities. EAP seeks to reduce the time associated with , not just reduce the time for the premarket review. In addition to the program, the FDA has published a separate draft guidance outlining the agency's current policy on the timeline for data to be collected after product approval and what actions are available to the agency if approval conditions, such as postmarket data collection, are not met. Advice on the use of surrogate or independent markers to support approval, similar to those seen for accelerated approval of prescription drugs, is included in the guidance.

"We are excited to offer a proposed program for expedited access for certain high-risk ," Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said in a statement. "The program allows manufacturers to engage early and often with the agency. We expect most devices that enter this program will be in the pre-clinical trial phase."

Explore further: Study examines expedited FDA drug approvals, safety questions remain

More information: More Information

Related Stories

FDA approves expanded indication for CRT devices

April 15, 2014

(HealthDay)—The U.S. Food and Drug Administration has approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D). ...

Recommended for you

Re-framing the placebo effect and informed consent

October 29, 2015

(Medical Xpress)—Imagine that your doctor knows from evidence-based studies that if he tells you about certain, small side-effects to a particular drug, you are significantly more likely to experience that side effect than ...

Can exercise be replaced with a pill?

October 2, 2015

Everyone knows that exercise improves health, and ongoing research continues to uncover increasingly detailed information on its benefits for metabolism, circulation, and improved functioning of organs such as the heart, ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.