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BRIEF-FDA Commissioner announces new steps to advance medical device innovation ‍​
October 24, 2017 / 3:45 PM / 2 months ago

BRIEF-FDA Commissioner announces new steps to advance medical device innovation ‍​

Oct 24 (Reuters) - U.S. Food and Drug Administration Commissioner Scott Gottlieb:

* Statement from FDA Commissioner Scott Gottlieb, on new steps to advance medical device innovation‍​

* FDA’s Gottlieb says to make medical device development process more efficient, FDA is releasing 3 new guidance documents related to medical devices‍​

* FDA’s Gottlieb says completed first qualification of a MDDT to provide objective platform for developing devices in cardiovascular health‍​

* FDA’s Gottlieb says one of the 3 new guidance documents related to medical devices is a draft delineating the FDA’s new “Breakthrough Devices Program”

* FDA’s Gottlieb says FDA is also releasing three new guidance documents related to medical devices‍​

* FDA's Gottlieb-other 2 guidances will help medical device innovators determine when to submit new 510(k) prior to making change to a legally-marketed device Source text: (bit.ly/2gz8DjJ)

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