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Regulatory Focus™ > News Articles > One of FDA's Top Device Regulators Stepping Aside

One of FDA's Top Device Regulators Stepping Aside

Posted 19 August 2014 | By Alexander Gaffney, RAC

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 at FDA's Center for Devices and Radiological Health (CDRH) will be 7 September 2014, the agency confirmed in an email.

Her position will be assumed on an acting basis by William "Bill" Maisel, who now serves—and will continue to serve—as deputy director for science and chief scientist at CDRH.

Foreman has been a leading figure at FDA, notably having testified on behalf of the agency on its stance on mobile app regulation. She has also been a key figure in the agency's evolving (and controversial) regulatory stance on premarket notifications [510(k)s].

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