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Improving Patient Care by Making Sure Devices Work Well Together
By: Bakul Patel Interoperability refers to the ability of medical devices to interact and for electronic health record systems to talk to each other using a common vocabulary. It is similar to the...
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FDA Brings Patients Into the Process
By: Michelle McMurry-Heath, M.D., Ph.D. What do patients really want? At the FDA, we ask that question every day and in all kinds of contexts. Earlier this year, the Center for Devices and...
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Filling Information Gaps for Women in Medical Device Clinical Trials
By: David Strauss, M.D., Ph.D. At FDA’s Center for Devices and Radiological Health (CDRH), results from clinical trials often serve as the foundation for our decisions to approve the most important...
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A CDRH Priority: Clinical Trials in the U.S.
By: Owen Faris, Ph.D., and Jeffrey Shuren, M.D., J.D. At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to approve the most important...
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Strengthening the Clinical Trial Enterprise for Medical Devices: An FDA/CDRH...
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...
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