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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
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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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
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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Physician Payment Sunshine: Kohl and Grassley Urge CMS to Complete Regulations by June
As numerous healthcare stakeholders wait for the Supreme Court to determine whether the individual mandate of the Affordable Care Act…
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Hospitals
DuVal and Associates – CLIENT ALERT 1/2012
In this CLIENT ALERT we offer you a four part series (contained in one document) covering our thoughts on…
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Hospitals
Clear as Mud: Obtaining & Marketing your 510(K) with Today’s FDA
Knowing how to get your application through FDA quickly can save millions of dollars in unnecessary investment burn. Mr. DuVal,…
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