FDA
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Hospitals
CDRH Wants To Hear From You
Excellent customer service means understanding and addressing, as appropriate, stakeholders’ and colleagues’ needs through: active listening, problem solving, seeking out…
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Hospitals
FDASIA at Year Two
By Margaret A. Hamburg, M.D. Anniversaries are a time for stock-taking and today, on the second anniversary of the Food…
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Uncategorized
Google Chief Regarding Not Moving Towards Healthcare “Regulatory Burden…so high”
“Regulatory burden in the U.S. is so high that I think it would dissuade a lot of entrepreneurs,” says Sergey…
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FDA Reveals 4 Year Plan
July 2, 2014 by Arezu Sarvestani The FDA outlines its vision for the 4 years ahead, generally staying the course on existing…
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Hospitals
FDA outlines expectations for human drug compounders, including registered outsourcing facilities
Today, the U.S. Food and Drug Administration issued several policy documents regarding compounded drug products for human use, as part…
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FDA proposes enforcement discretion for medical device data systems
June 30, 2014 by MassDevice By Yarmela Pavlovic and Jennifer Henderson In a 20 June 2014 draft guidance, the Food and Drug Administration…
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Uncategorized
FDA allows marketing of first wearable, motorized device that helps people with certain spinal cord injuries to walk
The U.S. Food and Drug Administration today allowed marketing of the first motorized device intended to act as an exoskeleton…
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FDA Encourages Medical Device Data System Innovation
By: Bakul Patel Thanks to advances in digital health, doctors and their patients are more frequently using computer systems to…
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Hospitals
How To Transfer Medical Device 510(k) Ownership
How To Transfer Medical Device 510(k) Ownership JANUARY 8, 2014 / MEDICAL DEVICE BLOG Medical device manufacturers might be surprised to know that…
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Hospitals
GET ON FDA’S CLOUD
Walter Eisner • Fri, June 20th, 2014 The FDA’s collective heads are in the clouds when it comes to “Big…
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Hospitals
DuVal and Associates – 510(k)s/IDEs: The New Normal?
Client Alert January 2012 510(k)s/IDEs: The New Normal? DEAR CLIENTS AND FRIENDS OF THE FIRM, In this CLIENT ALERT we…
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Hospitals
4 Ways to Make the Best Use of Medical Device Remote Audits
Posted by Rob Packard on June 19, 2014 This blog identifies how to use medical device remote audits effectively, save time and…
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FDA to Improve CDRH
June 12, 2014 by Brad Perriello The FDA details its plan to refine processes at the Center for Devices & Radiological Health,…
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FDA Applies Genome Sequencing in Outbreak Investigation
The U.S. Food and Drug Administration recently put whole genome sequencing technology — which maps the entire DNA sequences of…
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