FDA To Modify the 40-year-old 510(k) Clearance Process

Introduction

After nearly 40 years, the U.S. Food and Drug Administration (FDA) announced changes to the clearance process for medical devices, which at present relies on the comparison with the predicate devices available in the market.

FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, stated on Monday, “we believe firmly in the merits of the 510(k) process. But we also believe that the framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices.”

Under the 510(k) pathway process, new products are compared to the previously cleared devices to exhibit their safety and effectiveness. However, almost 20% of the approvals are based on the predicate that is as old as 10 years. The products might be safe to use but comparing them to old predicate devices does not provide any clear safety assurance.

The FDA announcement came a day after a year-long investigation report by the International Consortium of Investigative Journalists revealed 1.7 million injuries and 83,000 deaths linked to the medical devices approved and cleared by the FDA. In the coming year, the agency will finalize guidance presenting the modifications in the 510(K) pathway allowing the manufacturers to understand the importance of device safety and the need for medical innovation. The new approval process is expected to increase the number of De Novo applications, for which there are no approved predicate devices. The guidelines would be issued by the agency in the next few weeks for submitting De Novo applications.

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