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Science and Research (Medical Devices)

Science and Research (Medical Devices)

A core function of CDRH is to advance regulatory science, the science of developing new tools, standards and approaches to assess the safety, efficacy, quality, and performance of medical devices and radiation-emitting products. Science at CDRH includes laboratory and field research in the areas of physical, life, and engineering sciences as well as epidemiological research in postmarket device safety. Research is conducted in FDA laboratories and through collaborations with academia, healthcare providers, other government agencies and industry. CDRH relies upon this work to support its efforts ensuring public safety in areas as varied as medical imaging, medical device software, breast implants, and drug eluting stents.


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