Regulatory Review Executive Order Could Mean Changes at FDA

The FDA is likely to see its rules and guidances come under increased scrutiny now that President Barack Obama has initiated an overhaul of the country’s federal regulations. In an executive order signed last week, Obama ordered all government agencies to conduct a cost-benefit analysis before issuing a new regulation and to develop any regulations going forward in the least burdensome manner possible and with specific performance goals. In addition, agencies should assess all available alternatives to direct regulation before issuing a new rule, the order says.
Devices & Diagnostics Letter