Proposed Bipartisan Bill to Streamline 510(k) Process

Two members of the US House of Representatives introduced H.R. 2471, the Medical Product Review Harmonization Act of 2017 on May 18th. The bipartisan bill calls for amending the Federal Food, Drug, and Cosmetic Act to “provide for an alternative standard for substantial equivalence determinations for devices and for other purposes.” It aims to simplify repetitive regulations in the review process by allowing the FDA to clear certain Class II medical devices that comply with objective criteria developed and published by the FDA, such as guidance documents.

Bill sponsor Representative Mimi Walters said, “The improvement of medical care is due in large part to the innovation of the instruments and devices that carry out the procedures that keep us healthy. Unfortunately, unnecessary regulations hinder progress on new advancements that could save and improve lives.”

The FDA has already developed guidance documents that lay out specific testing and performance requirements, but cannot clear devices solely based on satisfying these requirements. The FDA must also review proof provided by the device’s sponsor that their device is substantially equivalent to a device currently on the market. By its very nature, this information is redundant to information already reviewed by the FDA. The bill founders argue that these redundancies delay patient access and lead to inefficient use of FDA resources.