Coalition calls for single regulation of IVDs, LDTs

The Combination Products Coalition said FDA should create a single regulatory framework for regulating both in vitro diagnostics and laboratory-developed tests. IVDs are subject to both FDA medical device regulations and CLIA requirements; LDTs, which are performed at a single laboratory, are only subject to CLIA regulations. The coalition said that if FDA approval is necessary to assure the safety and efficacy of IVDs, then "FDA's failure to regulate LDTs is putting patients at risk." The coalition said that conversely, if CLIA regulation alone is sufficient for LTDs, "FDA is making IVD manufacturers waste billions of dollars each year complying with unnecessary requirements."

The coalition's remarks came in a (see BioCentury, Nov. 25, 2013). ...