Lack of Predictability at CDRH Is Shutting Down Devicemakers

Devicemakers that have suffered from the unpredictability at CDRH are not reassured by the center’s initiatives to bolster its predictability and transparency. CDRH and devicemakers may have different interpretations of “transparent” and “predictability,” Mark Duval, a device attorney, said. “The administration today is predictably more onerous, and they are very transparent about it,” he added. To illustrate his point, he points to small devicemakers that are struggling to survive or have been forced to shut their doors by CDRH’s ever-changing requirements.
Devices & Diagnostics Letter