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On December 22nd, 2018, the Federal Government went into a partial shutdown. Forty one percent of the FDA staff ...
FDA is not the only organization that can review 510(k) submissions. Under the Third Party (“3P”) Review Program, ...
We witnessed several changes in the medical device industry in the year 2018. The impact of some changes was ...
Medical Device manufacturers selling their devices in the European Union are currently in a three-year transition ...
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