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Radiological Devices Panel to Meet

10/22/2009

Federal Register Notice: FDA’s Radiological Devices Panel of the Medical Devices Advisory Committee will meet 11/17-18, from 8 a.m. to 5:30 p.m. at the Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. On 11/17 the committee will discuss and make recommendations on the agency’s regulatory strategy for Full Field Digital Mammography Devices. It will also discuss public comments received in response to the publication of the draft guidance document, Class II Special Controls Guidance Document: Full Field Digital Mammography System. On 11/18, the committee will discuss and make recommendations on FDA’s regulatory strategy for computer-assisted detection (CADe) devices for radiological devices. Contact Toby Lowe, (301) 796-6512. To view this notice, click here.

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