FDA Tackles 510(k) Process

An event largely overlooked because of the Obama Healthcare Summit, the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) hosted a meeting to discuss how to bolster the process for marketing medical devices. Known as the 510(k) process, FDA requires manufactures to register with the government and notify them of any intent to release a device into the market.  The process allows the FDA to determine if the device is similar to another product already being sold or if it is a new piece of technology that needs to be classified.

Listening to speakers representing various stakeholders in the device industry, the theme of the meeting was to establish that the current 510(k) process was not broken. Though they agreed that the Center should be given more power to revoke the clearances of devices, most believe the process for Class II and Class III devices generally works well.

With the Institute of Medicine set to release their review of the 510(k) process next spring, the CDRH is beginning to work with the necessary stakeholders to bolster the government’s role in this process.  Action items the Center is likely to take on over the coming year include examining risk data to create a new submission process, working with manufacturers to create a modified 501(k) submission system for new devices, and increasing the transparency and availability of public information with regard to approved devices.   The revised process will be an important part of the healthcare device approval process as technology becomes a more central feature of the delivery process and we all work toward perfecting our country’s medical system.

Kevin Fickenscher, MD

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