MDMA Statement on IOM’s 510(k) Report

WASHINGTON, DC – MDMA President and CEO Mark Leahey issued the following statement regarding the Institute of Medicine’s (IOM) report on the “Public Health Effectiveness of the FDA 510(k) Clearance Process:”

"MDMA will continue to closely examine this report, though we completely disagree that the 510(k) pathway is ‘flawed’ and that the FDA needs to eliminate it.  While we are pleased that the IOM recognizes the crucial role medical devices have in health care, it is also important to remember that studies prove the 510(k) process has a strong track record on patient safety, and a complete overhaul of the system is simply not warranted.

"We remain concerned about reform efforts that would create additional uncertainties and slow patient access to medical therapies.   Moving forward, we will continue to work with FDA and all stakeholders to ensure a more predictable and reasonable process is in place."

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