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FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
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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 ...
FDA 510(K) Approved Facilities: Increasing GMP Inspections And Compliance Requirements
Indian medical device manufacturers are enhancing GMP compliance and embracing proactive strategies to meet rising USFDA ...
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The FDA outlines draft guidance on AI for medical devices
Both President Biden, and incoming President Trump, have made AI a top priority, and now the U.S. Food and Drug ...
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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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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 ...