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FDA Center for Devices & Radiological Health announces plans for 2008.(News & Analysis)
The US DHHS Food & Drug Administration Center for Devices & Radiological Health (CDRH) is considering developing various regulatory guidance documents in fiscal year 2008:
* Guidance on MDUFMA Reauthorization
--30-Day Notices & 135-Day PMA Supplements
--FDA & Industry Actions on Premarket Approval Applications
--FDA & Industry Actions on Premarket Notification Submissions
--Assay Migration Studies for IVDs
--Clinical Trials Using De-IDed Leftover Samples
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