Despite recent U.S. Trade Representative (USTR) decisions to exempt products from tariffs on China, the medical device industry worries about the [...]
Aimed at providing medical device manufacturers clarifications on unique device identification (UDI) marking policies for convenience kits, FDA has finalized its [...]
On May 8, 2019 FDA has finalized its guidance on the regulatory requirements applicable to laser products entitled “Final guidance - [...]
To streamline the medical device approval process and bring treatments to patients who need them faster and more efficiently, the US [...]
In an effort to address safety and quality issues emerged during medical device establishment inspections as quickly and adequately as possible, [...]
Donald Rucker, the National Coordinator for Health IT, provided a testimony before the House Committee on Energy & Commerce detailing the [...]
The President of the United States, Donald Trump, followed up on his presidential campaign promises to adjust the "long term abuse [...]
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