FDA Still Mulling Potential Diagnostics Reform Rule In Absence Of VALID

FDA continues to eye rulemaking as a potential pathway to revamp the regulation of laboratory-developed tests, after Congress in December failed to pass a key bill that would have created a risk-based regulatory framework for LDTs and established a user fee program for in vitro clinical tests. “Unfortunately, diagnostic testing reform was excluded from the legislation passed by Congress at the end of the year,” FDA spokesperson Jim McKinney said in an email to Inside Health Policy . “While we...