December 28, 2010
Testing Medical Devices
To the Editor:
“The Implants Loophole” (Business Day, Dec. 17) unfairly characterizes the Food and Drug Administration’s 510(k) review process — the process by which the majority of medical devices get to market — as a “loophole” that requires only “minimal testing” for changes to already proven products.
The F.D.A.’s review process provides a rigorous regulatory framework for determining the safety and effectiveness of new medical devices, while facilitating innovation that leads to improved treatment options for American patients.
This process is a risk-based, science-driven mechanism that the F.D.A. uses to define the controls necessary to ensure the safety and effectiveness of new medical devices. The F.D.A. reviews extensive specification and performance testing information, and, where the F.D.A. thinks appropriate, clinical data, before determining whether a product receives clearance.
Furthermore, the F.D.A.’s review process should not be viewed in isolation but as part of a comprehensive pre- and post-market regulatory system that ensures the continuing safety and effectiveness of medical devices.
Stephen J. Ubl
President and C.E.O., Advanced
Medical Technology Association
Washington, Dec. 21, 2010
