U.S. Rep. Larry Bucshon (R-IN) released a discussion draft of legislation on Tuesday that outlines a process for bringing innovative diagnostic tests to market.
The Diagnostic Accuracy and Innovation Act (DAIA) discussion draft released by Bucshon and U.S. Rep. Diana DeGette (D-CO) aims to bring greater certainty to the diagnostic industry while improving patient safety. The legislation would set forth a flexible, risk-based regulatory approach to diagnostic tests.
“Our discussion draft builds upon previous efforts to establish a modern framework for the regulation of diagnostic tests, which will benefit patients and advance precision medicine,” Bucshon and DeGette said in a joint statement. “This updated approach is an effort to improve public health, foster more innovation, and strike the right regulatory balance.”
Bucshon and DeGette collaborated with patient groups, researchers, laboratories, diagnostic test developers and other stakeholders on the DAIA discussion draft.
“We hope to continue a bipartisan dialogue in the 115th Congress that includes input from patient groups, clinical laboratories, manufacturers and other stakeholders,” the lawmakers said. “We look forward to getting additional feedback before moving forward.”
Under the bill, in vitro clinical tests would have an exclusive regulatory structure under the Food, Drug and Cosmetic Act that would be separate from the regulatory structure for traditional medical devices.
U.S. Food and Drug Administration jurisdiction over the development of tests and manufacturing activities would also be clarified under the bill. The Centers for Medicare and Medicaid Services would have jurisdiction over laboratory operations under an amended Clinical Laboratory Improvement Amendments framework.
Bucshon and DeGette are seeking feedback on the discussion draft through April 7.