CBSA and our members met with Senator Michael Bennet and Rep. Diana DeGette’s offices this week to discuss the Verifying Accurate Leading-edge IVCT Development (VALID) Act, recent federal legislation that would establish a new regulatory framework at the FDA for all diagnostic tests. The goal of the meeting was to provide feedback to health policy aides in their offices and ensure that any new regulatory framework creates a consistent and predictable pathway for in vitro clinical test (IVCT) developers.

During the meeting, CBSA applauded the leadership of Senator Bennet and Rep. DeGette in working to enact comprehensive diagnostic regulatory reform, and shared our support for a modern, risk-based approach that promotes public health and diagnostic innovation. We discussed our top priorities and concerns, including:

• the value of a technology certification program as part of the new framework, as a way to maintain high-quality testing while also advancing a least burdensome approach for developers;
• consistent application of a risk- based approach;
• how the new framework would harmonize with the Clinical Laboratory Improvement Amendments (CLIA); and
• the impact a new regulatory framework will have on diagnostic reimbursement.

Read CBSA’s comment letter on the VALID Act.

CBSA will continue to work with Senator Bennet and Rep. DeGette’s offices as the legislation moves forward and advocate for regulatory reform that can keep pace with innovation and ensure timely patient access to cutting-edge diagnostic technologies.