FDA to drop IVDMIA policy

FDA will not issue final guidance on, or implement draft guidance on, the regulation of in vitro diagnostic multivariate index assays (IVDMIAs). Instead, the agency has launched a review of its overall regulation of laboratory-developed tests (LDTs), Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH), told BioCentury on Wednesday. "LDTs do not have to seek premarket approval," Shuren said. FDA's new policy is consistent with recommendations from advanced diagnostics manufacturers and laboratories that were critical of the draft IVDMIA guidance (See BioCentury, Jan. 26, 2009).

As a first step, FDA will hold a public meeting on July 19-20 to discuss the oversight of LDTs, Shuren said. Shuren emphasized that FDA will take a deliberative approach to regulating LDTs. Following the meeting, the agency will craft a draft regulatory framework and seek public comment before implementing a policy. FDA's LDT policy "will be risk-based with phased implementation," Shuren said. FDA will exercise authority over tests if lack of validation could put patients at risk and "will apply our authority to facilitate innovation without compromising safety and effectiveness." ...