FDA proposes accelerated medical device approval plan

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 In addition to the program, the FDA has published a separate draft guidance outlining the agency's current policy on the timeline for data to be collected after product approval and what actions are available to the agency if approval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."

More information: More Information

add to favorites email to friend print save as pdf

Related Stories

FDA approves expanded indication for CRT devices

Apr 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 ...

Recommended for you

FDA OKs Cubist antibiotic for serious infections

13 hours ago

The Food and Drug Administration has approved a new medicine to fight complex infections in the abdomen and urinary tract, the fourth antibiotic the agency has approved since May.

Xtoro approved for swimmer's ear

Dec 18, 2014

(HealthDay)—Xtoro (finafloxacin otic suspension) eardrops have been approved by the U.S. Food and Drug Administration to treat swimmer's ear, clinically known as acute otitis externa.

Drug interaction identified for ondansetron, tramadol

Dec 18, 2014

(HealthDay)—In the early postoperative period, ondansetron is associated with increased requirements for tramadol consumption, according to a review and meta-analysis published online Dec. 10 in Anaesthesia.

New system targets germs in donated blood plasma

Dec 17, 2014

(HealthDay)—A new system designed to eliminate germs in donated blood plasma and reduce the risk of transmitting a plasma-borne infection has been approved by the U.S. Food and Drug Administration.

User 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.