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, ...
JD Supra5d
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 ...
Forbes1y
Medical Device Security Is A Top Challenge For Healthcare CIO
Food and Drug Administration (FDA) regulations mandate that all medical device vendors tighten their security features with processes to find and mitigate vulnerabilities. The FDA mandate is a ...
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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 ...
CNN17d
Which foods are ‘healthy’? FDA has new requirements for food labels
Requirements now include limits on saturated ... Improving access to nutrition information is an important public health effort the FDA can undertake to help people build healthy eating patterns ...
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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 ...