A new guidance document released by the US Food and Drug Administration (FDA) is intended to clarify the types of communication used by FDA and industry during the review of medical device submissions ...
Nearly a year and a half after first announcing an experimental pilot program that would allow its medical device review staff to better understand how the regulatory process occurs from the ...
The landscape of FDA medical device regulation has undergone a significant transformation. Today's regulatory environment presents both familiar challenges and entirely new complexities that device ...
Some scientists assigned double the number of new product applications for review Some deadlines for tobacco products will not be met and the start of new applications have been delayed, scientist ...
The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its medical device reviews by hosting discussions with the medtech industry and ...
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