Arzezu Sarvestani from massdevice.com wrote an intriguing article on FDA’s Center for Devices and Radiological Health’s (CDRH) outlined priorities for the upcoming 2014 year. One of their main priorities will be in streamlining its clinical trial program with hopes of becoming more efficient, consistent, and predictable. To accomplish this they will have fewer applications that require multiple cycles before approval. Going along with this view the CDRH will consider moving some of the pre-data requirements to post market. FDA will soon start looking for public remarks on the framework on which pre-data requirements can be moved to post market. To read the full article click here.
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