From the AAMi website – http://www.aami.org/newsviews/newsdetail.aspx?ItemNumber=7367
Posts tagged as “USFDA”
Safety and Performance Based Pathway – Guidance for Industry and Food and Drug Administration
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the…
Interesting findings – “results of the computer-simulated VICTRE trial are consistent with the comparative trial using human subjects and human image interpreters. While further research…
Interesting findings and recommendations – Medical Device User Fee Amendments IV Independent Assessment of Food and Drug Administration’s Device Review Process Management – Final Report…
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S.…
Public docket for comments – USFDA Proposes to End Temporary Extension of GUDID’s Grace Period
A new program focusing on “to encourage innovation and market entry of device technologies that are safer than current alternatives”. Read here: Statement from FDA Commissioner…