Lawyers: FDA’s CLIA Waiver Guidances Give Industry More Flexibility

Industry lawyers expect more in vitro diagnostic test makers to apply for CLIA waivers thanks to newly issued FDA guidances that make the process less prescriptive and clarify that tests for which trained and untrained users get comparable results are entitled to a waiver. Test makers that get their tests cleared by FDA for home use or meet the waiver criteria, which the lawyers say just became easier, can get out from under CMS’ CLIA certification requirements. One lawyer told...