U.S. Subcommittee on Health convenes to discuss 21st Century Cures Initiative
"In order to advance each of them, we must establish a regulatory environment that fosters the development of and access to innovative, accurate and reliable diagnostic testing," Rep. Joseph Pitts (R-PA), chair of the subcommittee, said. "Today’s discussion puts us on that path."
The hearing included testimony from both FDA and CMS officials.
“FDA is committed to developing a final policy for oversight of LDTs that encourages innovation, improves patient outcomes and strengthens patient confidence in the reliability of these products,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said.
Full Committee Chairman Fred Upton (R-MI) called the tests "increasingly important and complex."
"We must ensure that our laws and regulations keep pace so that innovation in this space continues and patients benefit from accurate and reliable tests,” Upton said.
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U.S. House Committee on Energy and Commerce 2125 Rayburn House Office Building Washington, DC 20515