Jeff Shuren

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FDA’s Shuren on Tightening Future FDA Review of High-Risk Devices

Dr. Jeffrey Shuren, CDRH Mesh Medical Device News Desk, April 20, 2017 ~ FDA’s Jeff Shuren writes about how to serve two masters, public safety and the need of manufacturers for fast access to the marketplace for high-risk devices. Can anyone serve two masters? For seven years, Dr. Jeffrey [...]

By |2017-04-20T10:36:33-04:00April 20th, 2017|FDA News|4 Comments

FDA Steps Up Medical Device Monitoring – It’s About Time

Bar Code Could the entire mesh mesh have been averted much sooner before perhaps one million women were implanted with controversial transvaginal mesh? Yes, if the U.S. tracked medical devices the way it’s done elsewhere. The Food and Drug Administration (FDA) is finally taking a step in that [...]

By |2013-09-24T13:59:47-04:00September 24th, 2013|FDA News|13 Comments

FDA and Med Device Makers Make it Official

by Jane Akre// DECEMBER 7, 2011 //Shuren Signs Memo of Understanding// Minnesota loves its medical device industry. Even Senator Al Franken (D-MN) who used to parade on Saturday Night Live with a satellite dish on his head as a roving comedic newsman, has gotten pretty serious when it [...]

By |2011-12-08T04:21:45-05:00December 8th, 2011|FDA News|2 Comments