The U.S. Senate Committee on Health, Education, Labor and Pensions favorably reported a measure today that would reduce regulatory hurdles for the approval of medical devices.
The “FDA Device Accountability Act of 2015” (S. 1622), sponsored by Sens. Richard Burr, R-N.C.; and Al Franken, D-Minn., and co-sponsored by Mark Kirk, R-Ill., is intended to ensure the “least burdensome means” of evaluating medical devices, according to the bill’s authors. It requires that any FDA employee involved in the premarket submission process of medical devices receives training to make the approval of those devices easier, as well as an audit to assess the effectiveness of their training.
“Our bill also permits device innovators to work with local or central [institutional review boards], as in the case with drug clinical trials,” Burr said. “Providing innovators and the agency with this option is another way our bill is supporting more timely access to medical devices. That’s a good thing.”
The bill also calls for the FDA to re-examine its guidance on the approval of Clinical Laboratory Improvement Amendments (CLIA) waivers for diagnostic tests administered at the point of care, including physicians’ offices and EDs.
“In response to concerns that the current FDA guidance on CLIA waivers has resulted in significant regulatory challenges, our bill instructs the FDA to issue new guidance on the regulation of CLIA-waived tests,” Burr said.