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Sponsor Presentation posted for Sept. 24, 2015 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting
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FDA Presentation posted for Sept. 24, 2015 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting
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FDA Voice
By: Nina L. Hunter, Ph.D., and Robert M. Califf, M.D. Last week we announced FDA’s first-ever Patient Engagement Advisory Committee, which will provide advice to the FDA Commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients. We thought it would be good to step back and fill…
Posted the FDA-Industry MDUFA IV Reauthorization Meeting Minutes, September 9, 2015
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FDA Voice
By: Owen Faris, Ph.D., and Jeffrey Shuren, M.D., J.D. Every day, millions of Americans rely on FDA approved or cleared medical devices to save, sustain, or improve the quality of their lives. At the Center for Devices and Radiological Health (CDRH), we are committed to patients having access to high-quality, safe, and effective medical devices–as…
Pathway Genomics Letter – September 21, 2015 (PDF
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140009 added)
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FDA Voice blog – FDA Announces First
By: Nina L. Hunter, Ph.D., and Robert M. Califf, M.D. Although it may seem odd in retrospect, the development of new technologies intended to improve patients’ lives has largely relied upon expert opinions rather than asking patients and families directly what they consider most important. Nina L. Hunter, Ph.D., a Regulatory Scientist in FDA’s Center…
Meeting Materials posted for Sept. 24, 2015 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting
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