Current activity at the FDA suggests a shift toward heavier device regulation.

First, FDA has commissioned the Institute of Medicine (IOM) to study the premarket notification program used to review and clear certain medical devices marketed in the United States. Second, the Center for Devices and Radiological Health (CDRH) will convene its own internal working group to evaluate and improve the consistency of FDA decision-making in the 510(k) process.

The agency strives to balance its dual goals of fostering innovation while ensuring safety and efficacy, officials say. However, the fast rate of technological advances is prompting the agency to revisit the adequacy of the its premarket notification program in meeting these twin goals.
The Advanced Medical Technology Association (AdvaMed) indicated that it supports the current risk-based approach to medical device regulation.

"AdvaMed strongly supports FDA's current risk-based approach to medical device regulation. The 510(k) process gives robust protections to American patients and promotes medical innovation by providing FDA the flexibility it needs to ensure the safety and effectiveness of low- and moderate-risk medical devices," said Janet Trunzo, executive vice president of technology and regulatory affairs for the Association. "We look forward to IOM's thorough and unbiased analysis of the 510(k) process as we believe it will underscore the strengths of FDA's current regulatory approach..."

The IOM review is slated for completion in 2011.

The FDA classifies medical devices into three categories according to their level of risk from Class III devices representing the highest level of risk down to Class I and Class II devices. New technologies or uses may require fresh premarket approval.

For more information:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

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