Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office was quoted in Medical Design Technology in “Assessing the Good and the Bad in the LDT Guidances,”by Richard Park.
Following is an excerpt:
“A single system with the right balance, one that provides assurances of safety, effectiveness, and quality while not creating unnecessary barriers to IVD innovation, will give patients the best access to the best IVD tests,” said Bradley M. Thompson, an attorney at Epstein Becker Green (Washington, DC). “FDA’s framework gets us a long way toward that goal.” ….
“Bringing all the stakeholders together, such as FDA, the Centers for Medicare and Medicaid Services (CMS), IVD manufacturers, clinical labs, patient groups, etc., will be important to all the work that will be going on in the months and years ahead,” said Thompson. “FDA’s LDT draft guidance provides some opportunity for that through the comment process, public meetings that the agency has scheduled, etc. However, having a more formal and comprehensive process, similar to what Congress mandated for health information technology, to bring everyone together to talk about how we can make the best system for all IVDs, and not just LDTs, would help in developing the optimal regulatory system to give patients the best IVD tests.”
