The Food and Drug Administration (FDA) is responsible for protecting and promoting the public health of US citizens. In keeping with this mission, FDA’s Center for Devices and Radiological Health (CDRH) is tasked with assuring the safety, effectiveness, and quality of medical devices, assuring the safety of radiation-emitting products, fostering innovation, and providing the public with accurate, science-based information about the products we oversee, throughout the total product life cycle. 1 In order to enhance our ability to fulfil our mission, CDRH developed a strategic plan to identify priority areas for 2010. One of our goals is to proactively help facilitate medical device innovation and address unmet public health needs. 2 To accomplish this objective, CDRH believes it is critical to leverage our regulatory authority and unique understanding of the products we oversee
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