Pew Testifies Before Senate Committee on Need to Strengthen Diagnostic Tests’ Oversight

Related legislation would give FDA authority to set risk-based requirements for all tests

Pew Testifies on Need to Strengthen Diagnostic Tests’ Oversight

On April 5, Liz Richardson, project director of The Pew Charitable Trusts’ health care products project, testified at a U.S. Senate Health, Education, Labor, and Pensions Committee hearing on the Food and Drug Administration’s user fee agreements. She discussed the importance of FDA user fees in providing the agency with resources to facilitate the development of urgently needed medical products. She also spoke about the role of the agreements in providing an opportunity for Congress to pass additional public health reforms, such as the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would strengthen and update current medical device regulations and enable FDA to adopt a risk-based approach to diagnostics oversight that balances safety and innovation.

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