Discussion Part of Ongoing Hearings Examining User Fee Agreements
WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today held a hearing examining the medical device user fee program. As reauthorized by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, the Medical Device User Fee Amendments (MDUFA) support the review and regulation of medical devices.
“In 2009, it took an average of 427 days before FDA even reached a decision on a premarket approval application (PMA). As of 2015, the average review time was down to 276 days – a 35 percent decrease. More work lies ahead, but great strides have been made,” stated full committee Chairman Walden (R-OR).
“FDASIA included meaningful regulatory reforms, improved communication between industry and FDA, and increased accountability at the Center for Devices and Radiological Health (CDRH). It is important that the next medical device user fee agreement continue to build upon the progress made in FDASIA, as well as the good policies members of this subcommittee championed in the 21st Century Cures Act,” said Chairman Burgess. “I am encouraged that the proposed agreement transmitted to Congress in January contains many promising elements that will be good for FDA, industry, and most importantly, patients.”
Rep. Fred Upton (R-MI) highlighted the artificial pancreas as an innovative advancement made possible through this process. In this exchange with Dr. Jeffrey Shuren, Director of FDA’s CDRH, Rep. Upton asked what other once-thought impossible advancements are on the horizon. Dr. Shuren said we can expect to see more user robotics and less invasive surgeries – like using an ultrasound for a surgical procedure instead of a scalpel. “I think the U.S. can truly be the world’s leader if we continue on the trajectory we’ve been on,” stated Dr. Shuren.
Ms. Diane Wurzburger, Executive of Regulatory Affairs for GE Healthcare, spoke as member of the Medical Imaging and Technology Alliance (MITA), saying, “Advancements in medical imaging are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. …This agreement, negotiated between FDA and the medical device industry, advances our shared goals of ensuring that patients have timely access to the most innovative devices and diagnostics necessary for the public health.”
For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click HERE.