New bill would allow manufacturers of certain medical device to bypass elements of FDA’s existing process.
In a press release, Senator McCain said that streamlining regulatory approval will “improve patients’ access to safe and effective medical devices.” Senator Casey underscored that the bill will “protect consumers and…help our nation’s manufactures innovate.”
The bill, called the Safe, Efficient and Transparent Medical Device Approval Act (SET Device Act), would require the Food and Drug Administration (FDA) to speed up its evaluation of medical devices of low to moderate risk that have no existing substantial equivalent. The category of “medical devices” encompasses a wide range of items, from tongue depressors to surgical devices to in vitro diagnostic products.
Currently, devices without an existing substantial equivalent are categorized as class III devices. This classification subjects these devices to greater scrutiny than either class I or II devices because they require an FDA investigation into whether the device is substantially new. This investigation can lengthen the approval process, even for devices that are readily identifiable as unique.
To address this problem, the SET Device Act would allow manufacturers to apply for direct approval of an innovative device by submitting a classification request in which they could declare explicitly that there is no similar device already on the market. If the FDA accepts the request, then the device would be assigned a final classification without going through the similar-device investigation process.