In a Tuesday Wall Street Journal op-ed piece, President Obama announced a newly signed executive order that pushes for more efficient regulation throughout government agencies, including the FDA. "The FDA will lay out a new effort to improve the process for approving medical devices, to keep patients safer while getting innovative and life-saving products to market faster," Obama explained. But the new guidelines had some in the community worried as they wait to hear how the changes would be implemented.
Today, the FDA released a list of 25 actions that will improve the 510(k) system, including the creation of a new Center Science Council that will help standardize the review process and streamlined processes for lower-risk devices. And according to Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, the FDA's actions will create "a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe and effective technologies to patients quickly."
Some catheters and diagnostic devices will be considered lower-risk medical devices and must submit 510(k)s, or premarket notification submissions.
"Despite a lot of heated rhetoric, our efforts over the past two years to modernize our regulations have led to smarter--and in some cases tougher--rules to protect our health, safety and environment," Obama said. "Yet according to current estimates of their economic impact, the benefits of these regulations exceed their costs by billions of dollars."
Members of the industry were quick to react to the plan. "AdvaMed is pleased with FDA's thoughtful analysis of comments by industry and its willingness to listen to views and concerns expressed by Members of Congress, patient and physician groups and industry," Stephen Ubl, president and CEO of AdvaMed, says in a statement. "Much of the agency's plan supports our long-standing position that the 510(k) process is fundamentally sound and has been beneficial to American patients. The plan also generally adheres to our principles that any changes to the 510(k) process should be targeted, have a corresponding health benefit and support timely access to new treatments and cures."
Ubl adds that the plan is a "good first step" to address "some of the major problems with the program, including improving consistency, providing greater reviewer training, and streamlining of the de novo process."
The CDRH is still reviewing the 510(k) system after accusations that the process is unpredictable and inconsistent. These 25 recommendations come after the CDRH's 55 recommendations in August 2010. The center will hold off on any major moves until after the release of an Institute of Medicine report scheduled for the summer, as MassDevice notes.
Editor's note: Story updated after the release of the list