CDRH: ‘Corrective Fix’ Recalls Part of Postmarket Strategy

Devicemakers are finally getting answers from the Center for Devices and Radiological Health (CDRH) about its “corrective fix” pilot program. And they don’t like everything they’re hearing.

The pilot, which requires some manufacturers to recall older devices when CDRH approves improvements, has been the source of rumors among devicemakers, but its existence had not been officially confirmed by CDRH.

CDRH came clean at the 2010 Food and Drug Law Institute annual conference when Megan Moynahan, network leader for the center’s Electrophysiology and Monitoring Devices Network, acknowledged that the corrective fix is part of Signal Escalation, a postmarket transformation program CDRH quietly