FDA Lists Planned Device Guidances for FY 2014
The Food and Drug Administration posted a list of upcoming guidance documents on medical devices that it intends to publish in fiscal year 2014, as required by the Medical Device User Fee Amendments of 2012. The list is divided into…
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an “A” list of priority guidances, and a “B” list that FDA will get to if it has enough remaining resources. According to FDA’s website, guidances the agency plans to issue in fiscal year 2014 include one on the Global Unique Device Identification Database, one on the evaluation of automatic Class III designation, and several detailing premarket notification requirements.