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 In addition to the program, the FDA has published a separate draft guidance outlining the agency's current policy on the timeline for data to be collected after product approval and what actions are available to the agency if approval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: Pediatric devices still have few premarket studies in children

More information: More Information

Related Stories

Pediatric devices still have few premarket studies in children

April 15, 2014
(HealthDay)—Most high-risk pediatric devices are approved based on trials that don't involve children under 18 years of age, according to a study published online April 14 in Pediatrics.

Study examines expedited FDA drug approvals, safety questions remain

October 28, 2013
Fewer patients were studied as part of expedited reviews of new drugs approved by the U.S. Food and Drug Administration (FDA) in 2008 and some safety questions remain unanswered, according to a study published by JAMA Internal ...

Most high-risk cardiac devices in use today approved as modifications to previously-approved devices

January 21, 2014
The Food and Drug Administration (FDA) ensures that high-risk medical devices, such as implantable cardioverter-defibrillators and pacemakers, are safe and effective through its premarket approval (PMA) pathway, during which ...

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). ...

FDA chief defends approval of hydrocodone drug

March 13, 2014
The head of the Food and Drug Administration says the much-debated painkiller Zohydro fills an "important and unique niche" for treating pain.

Recommended for you

Mind-body therapies immediately reduce unmanageable pain in hospital patients

July 25, 2017
Mindfulness training and hypnotic suggestion significantly reduced acute pain experienced by hospital patients, according to a new study published in the Journal of General Internal Medicine.

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

0 comments

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.