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). ...