GOPers want answers on draft guidances; FDA releases April 2014 510(k)s; prosthetic arm wins FDA nod; and more | Medtech regulatory news for the week of May 12, 2014

Here's a look at some of the top regulatory stories for medical device companies this week: Senate Republicans want answers from FDA commish Hamburg on draft guidances; Medtech regulation: FDA releases April 2014 510(k) decisions; Prosthetic arm that translates muscle signals into action wins FDA approval; FDA warns Cook Medical on unapproved changes to Evolution lead extractor; FDA: Foreign medtech firms receive excess manufacturing violations.

Senate Republicans want answers from FDA commish Hamburg on draft guidances

May 8, 2014 by Brad Perriello

Cook Medical, DEKA Research and Development Corp., Food & Drug Administration (FDA), U.S. Senate

News Well, Regulatory/Compliance

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