FDA plans to revamp 510(k) guidelines

The FDA has proposed new guidelines for the 510(k) process which allows devicemakers to gain accelerated approval for devices similar to those already on the market. Companies complain that the current process is inconsistent and confusing, while critics say the FDA doesn't require enough safety information for new devices.

Now the FDA will require devicemakers to submit a summary of all safety information for their products. This was not required previously, causing the agency to go back and forth with developers asking for more data and delaying the approval process. "It's mind-boggling that this information wasn't required before" Washington Analysis analyst Ira Loss tells Bloomberg. "With drug approvals, you have to submit full safety and efficacy data," when pursuing an NDA. The FDA plans to create a Science Council to enforce quality and consistency in the new guidelines.

Devices approved under the 510(k) process must be "substantially equivalent" to a device already on the market. But there's some confusion among agency employees as to what exactly that phrase means. As part of its proposed plan, Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, says the FDA will clearly define the term. Finally, the agency will also streamline the approval process for low-risk devices that don't require human studies.

Critics of the plan say the proposed guidelines are too industry-friendly and want more complete safety and efficacy trials of the devices. "We could be spending billions of dollars on products that don't work and aren't safe" Diana Zuckerman, president of the National Research Center for Women & Families in Washington, tells Bloomberg.

- read the Bloomberg article

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