. – On Monday, Representatives Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) released a discussion draft of the Diagnostic Accuracy and Innovation Act (DAIA), which would provide a predictable and timely path to market for innovative 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. “This updated approach is an effort to improve public health, foster more innovation, and strike the right regulatory balance. We hope to continue a bipartisan dialogue in the 115thCongress that includes input from patient groups, clinical laboratories, manufacturers, and other stakeholders. We look forward to getting additional feedback before moving forward.”
The DAIA addresses longstanding issues with the regulation of diagnostic tests and will bring much-needed certainty to patients, providers, and industry. This legislation would establish flexible, risk-based approach that applies the same regulatory principles to the same activity regardless of where the test is developed.
In vitro clinical tests (IVCTs) would have their own regulatory structure under the Food, Drug, and Cosmetic Act—separate and apart from traditional medical devices—that was developed with their unique attributes in mind from the outset. To eliminate duplicative regulation, the legislation clearly establishes FDA jurisdiction over test development and manufacturing activities and maintains oversight of laboratory operations under the Centers for Medicare and Medicaid Services (CMS) pursuant to an updated Clinical Laboratory Improvement Amendments (CLIA) framework.
The DAIA has benefited from collaboration with patient groups, researchers, laboratories, diagnostic test developers, innovators, and others.
Bucshon and DeGette are requesting feedback and comments on the discussion draft from stakeholders. Comments can be submitted Jeffrey.Lucas@mail.house.gov and Polly.Webster@mail.house.gov by April 7, 2017.
DAIA DISCUSSION DRAFT
DAIA SECTION BY SECTION