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  • Regulatory NewsRegulatory News

    CDRH Compliance Director Silverman Leaving FDA

    The longtime director of the Center for Devices and Radiological Health's (CDRH) Office of Compliance, Steve Silverman, plans to leave the US Food and Drug Administration (FDA) next week to pursue other opportunities, press officials have confirmed to Regulatory Focus . Silverman has been a central figure in CDRH's " Case for Quality ," an effort to improve compliance among medical device manufacturers by focusing on common quality errors across the device industry. "We...
  • Regulatory NewsRegulatory News

    One of FDA's Top Device Regulators Stepping Aside

    One of the US Food and Drug Administration's (FDA) top medical device regulators, Christy Foreman, will soon be giving up her position to focus on tobacco regulation at the agency. In an announcement on 19 August 2014, FDA said that Foreman—now director of the Office of Device Evaluation (ODE), the office which oversees approval of all medical devices in the US—will soon assume a new, as-yet undefined role at FDA's Center for Tobacco Products (CTP). Foreman's last day...