AdvaMed Statement on Senate HELP Committee Hearing on FDA’s Medical Device Approval Process


 Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), released the following statement on today’s Senate Health, Education, Labor and Pensions Committee hearing, “Medical Devices: Protecting Patients and Promoting Innovation”:

“AdvaMed commends the HELP Committee for holding this important hearing. The medical technology industry is committed to ensuring patients have access to safe and effective medical devices and  diagnostics while advancing America’s leadership in medical innovation.

“A predictable and efficient FDA review process and reasonable, risk-based standards of evidence are essential to achieving these twin goals. The 510(k) premarket review path has proven to be a rigorous regulatory framework with an excellent safety record – as demonstrated in several recent studies.

“It’s critical to the future of medical innovation that inefficiencies and the lack of consistency in FDA’s performance – resulting in significant increases in review times in recent years – be addressed. To the agency’s credit, it has recognized the challenges it faces and has proposed a number of policy changes.
The medical technology industry is committed to working with FDA and Congress to ensure these improvements achieve their objectives.”



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

AZBio is an AdvaMed partner organization.


Posted in Advocacy and Regulations, AZBio News.