BioCentury
ARTICLE | Politics & Policy

Labs challenge FDA authority over LDTs

June 6, 2013 12:32 AM UTC

The American Clinical Laboratory Association (ACLA) filed a (see BioCentury, Extra, June 3).

FDA has long asserted its authority to regulate LDTs, but has thus far chosen to leave oversight to state governments, CMS and the Centers for Disease Control and Prevention (CDC), which have authority to require demonstrations of analytic validity under the Clinical Laboratory Improvement Amendments (CLIA). ...