Shuren: Animosity Toward FDA Is Hurting Premarket Process

As industry has become more vocal in criticizing the regulatory process for devices, it may actually be hurting, rather than helping, its chances of seeing any real change, CDRH Director Jeffrey Shuren says. A barrage of studies analyzing the review process in recent months, along with criticism from various groups in Washington, D.C., is taking its toll on CDRH staff morale, Shuren told devicemakers June 9 at MDMA’s 17th Annual Meeting. “The adversarial environment in Washington is actually getting in the way” of improving the premaket review process, he said.
Devices & Diagnostics Letter