The Senate Health, Education, Labor and Pensions (HELP) Committee hearing on "Medical Devices: Protecting Patients and Promoting Innovation," prompted the following from AdvaMed President and CEO Stephen Ubl:
"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."