FDA’s Response

This investigation into 501(k) was made at the request of FDA, which petitioned IoM in 2009 to evaluate its medical device approval process. IoM’s recommendations may be more drastic, however, than what FDA expected.

Rather than make suggestions on how to improve the 501(k) system, the report focuses on how FDA can create a new and better medical device regulatory framework, one which facilitates innovation, is self-sustaining and self-improving, based on sound science and straightforward and fair.

“While current information is not adequate to immediately start designing a new framework, we believe the agency can get the necessary data and establish a new process within a reasonable time frame. FDA’s response to the IoM’s findings was swift,” Challoner said.

 In a press release sent the same day the IoM’s report was released, FDA officials defended the 501(k) process, stating that the IoM recommendations were too extreme.

“The 510(k) program has helped support a robust medical-device industry in the U.S. and has helped bring lower-risk devices to market for the patients who need them,” said Jeffrey Shureh, MD, director of FDA’s Center for Devices and Radiological Health (CDRH). “FDA believes that the 510(k) process should not be eliminated, but we are open to additional proposals and approaches for continued improvement of our device review programs.”

FDA announced it would seek public comment on the IoM report and noted that many of the problems identified by the report are being addressed by the agency. These include plans to draft guidance to streamline the path to market for low- and moderate-risk devices that are not substantially equivalent to an existing device, and to clarify aspects of the substantial equivalence reviewer process.

Last month, FDA also released draft guidelines on how to conduct better clinical studies for high-risk medical devices. The proposed guidance outlines the agency’s expectations for clinical trial design issues such as minimizing data bias, setting appropriate study objectives and selecting the appropriate type of study. While the guidance is focused primarily on premarket approval for high-risk devices, FDA has noted that the advice can be used to help support 510(k) submissions. FDA is asking for public comment on the draft guidelines.

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