Are The FDA’s New Regulations On Medical Devices Making A Difference?
With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...
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FDA Sued Over Laboratory Developed Tests Final Rule
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed ...
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FDA Breakthrough Device Designation: Clinical Evidence And Medicare Payment Policies
While FDA evaluation of medical devices is based on “reasonable ... have undergone post-approval clinical studies. Without CMS’s requirements or incentivization to conduct clinical utility ...
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Few medical devices are designed for children. An FDA-Children’s National collaboration aims to change that.
Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the ...
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Evolving Regulatory Protections for Research Participants
In a conversation with The Regulatory Review, Ropes & Gray partner David Peloquin discusses how clinical research studies are ...
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Which foods are ‘healthy’? FDA has new requirements for food labels
The US Food and Drug Administration has finalized new standards that foods must meet before they can be labeled as “healthy.” Requirements now include limits on saturated fat, sodium and added ...
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Which foods are ‘healthy’? FDA has new requirements for food labels
(CNN) — The US Food and Drug Administration has finalized new standards that foods must meet before they can be labeled as “healthy.” Requirements now include limits on saturated fat, sodium and added ...