DTWG is a coalition of leading in vitro clinical test manufacturers and laboratories. DTWG members are committed to advancing patient care through the development, manufacture and performance of high quality, high value diagnostic tests.

DTWG members share with other stakeholders the mission of providing physicians and patients access to analytically and clinically valid in vitro clinical tests using risk based, least burdensome principles. DTWG seeks to advance innovation and to eliminate duplicative or non-value-added regulation.

DTWG is focused on developing a consensus, bipartisan legislative approach to the current regulatory issues surrounding diagnostic tests. DTWG believes that diagnostic tests are inherently different than therapeutic medical devices and that the current regulatory framework for oversight of medical devices does not fit diagnostic tests.  Rather a regulatory system that is designed specifically for diagnostic tests is needed.

DTWG has worked with its members and with other key stakeholders, including FDA, to develop and advance core legislative principles designed to improve diagnostic test oversight, provide clear jurisdictional boundaries, and provide certainty to all stakeholders.  These consensus positions provide much of the basis for recent legislative approaches to diagnostic tests.  Over the past several years, a bipartisan, bicameral set of congressional sponsors has been working on this legislation.

• • Patients come first;
  • IVCTs are different from therapeutic devices;
  • Systems and processes should be tailored to IVCTs;
  • The same activity should be regulated the same way;
  • There should be clear, non-overlapping jurisdictional lines that recognize the distinct roles of FDA, CLIA, and states;
  • Innovation needs to be supported, including through appropriate modification provisions;
  • Least burdensome principles must be utilized;
  • Appropriate grandfathering and transition provisions are needed;
  • Utilization of rulemaking for substantive provisions; and
  • Risk based regulatory structure with appropriately stratified and transparent risk classifications.