FDA Slams Study That Accuses It of Stifling Device Innovation

The FDA is skeptical about an industry-funded study that claims the agency is stifling device innovation and falling behind strides being made in the EU. Citing “several significant flaws,” FDA spokesman Dick Thompson said the study “compared apples to oranges because companies come to the FDA earlier in the device development cycle than they do in the EU.” The agency also is critical of the low response rate for the study. About 20 percent of the more than 1,000 companies contacted for the survey responded. The low response rate may have led to biased results, Thompson added.
Devices & Diagnostics Letter