FDA 510(k) Plan is Step in Right Direction

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement on FDA’s release of its implementation plan for changes to the 510(k) medical device premarket clearance process:

“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. 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.

“The plan is clearly a good first step that will address some of the major problems with the program, including improving consistency, providing greater reviewer training, and streamlining of the de novo process.

“In addition, FDA’s plan drops or defers for IOM review many proposals that would have significantly slowed patient access to new diagnostics and treatments and placed significant burdens on industry without corresponding health benefits.

“The critical next step is how FDA implements the plan through guidances and regulations. Those details will determine whether today’s proposed changes will improve patient access and American competitiveness.

“As FDA moves forward, we look forward to working with it to address the full spectrum of issues that have contributed to unacceptable delays and inconsistency in the review process. It is time to take the next steps to ensure that patients have timely access to the latest medical advancements and that American innovation continues to lead the world.”

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.