Posted 07 February 2012
By Alexander Gaffney
Sens. John McCain (R-AZ) and Bob Casey (D-PA) introduced legislation on 3 February that would remove certain regulations that the senators believe is hurting medical device manufacturers and "streamline the pathway" that manufacturers use to bring their innovative products to market.
Their bill, the Safe, Efficient, and Transparent Medical Device Approval Act (SET Device Act) (S. 2067), would require the US Food and Drug Administration (FDA) to modify the de novo application process to allow new products to be evaluated directly, and without needing "to determine if there are similar products already on the market".
The de novo application pathway is "an approval mechanism by which the Food and Drug Administration may down-classify, to class I or class II, devices that have no predicates and thus are designated class III, but are deemed to be of low to moderate risk."
Medical devices are currently evaluated according to three device classes, with class I representing low-risk devices, class II representing moderate risk devices and class III representing high-risk devices.
Medical device industry group AdvaMed immediately came out in support of the bill, saying that they "believe the under-utilized de novo process has the potential to play a key role in the regulation of medical devices."