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Hospitals
Medtech insiders respond to FDA’s 510(k) split-predicate ban
August 6, 2014 by Arezu Sarvestani The FDA’s new guidance against split predicates in medtech 510(k) applications gets a largely warm welcome…
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Hospitals
FDA names 107 devices it will exempt under new guidelines
August 4, 2014 | By Joseph Keenan The FDA released a list of 107 medical devices it will exempt from its 510(k) premarket notification regulations…
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Hospitals
FDA Often Sees No Data, Speaks No Data, Hears No Data—A Failure to Review Data in a 510(k)
Is FDA not reviewing your data in a 510(k) submission? Have you ever received a Not Substantially Equivalent (NSE) letter…
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Hospitals
Medical device makers face new obstacles to European approval
July 30, 2014 by Arezu Sarvestani New materials regulations in the European Union mean medical devices have one more layer of red…
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Hospitals
FDA cuts fiscal 2015 user fees
July 30, 2014 by Brad Perriello The FDA is cutting the fiscal 2015 user fees paid by medical device companies to have…
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Hospitals
Final rule prohibits “split predicates” under 510(k) process
July 29, 2014 by Arezu Sarvestani Medical device regulators clamp down on the 510(k) review pathway, prohibited manufacturers from splitting their primary…
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Hospitals
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
FDA developed this document to provide guidance to industry and FDA staff about current review practices for premarket notification (510(k))…
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Hospitals
What you need to know about the FDA’s UDI system final rule
Jay Crowley, Vice President and UDI Practice Leader at USDM Life Sciences Amy Fowler, RAC, J.D., Associate at DuVal &…
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US FDA publishes insight into 510(k) Substantial Equivalence determination process
July 21, 2014 by MassDevice The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest…
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Uncategorized
A Curriculum for Medical Device Progress
By: Francis Kalush, Ph.D. Horace, the greatest Roman poet of antiquity, spoke of the need to “seek for truth in…
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Spine
Warning Letter for Spinal Elements
[gview file=”https://orthospinenews.com/wp-content/uploads/2014/07/Spinal-Elements.pdf” save=”1″]
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Uncategorized
Is the Agency Regulating the Medical Device Industry Out of Existence?
Whether your company is an established Fortune 500 or a boutique-sized company on its way to larger opportunities in the…
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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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