Regulatory
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July 2014 PMA Approvals
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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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Uncategorized
FDA Proposes Medical Device Rule to Simplify Classification Process
The Food and Drug Administration is proposing to amend its regulations governing classification and reclassification of medical devices to conform…
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FDA: 522 Reform Could Lead to More Discussions, Longer Response Time
The FDA will consider adding a mandatory pre-522 discussion period before issuing postmarket surveillance orders, officials at an FDA public…
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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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Yeah, Sure… Like We Are Going To Believe That
FDA device chief Shuren: Recession played a role in pushing medical device industry to EU Dr. Jeffrey Shuren tells a…
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NUORTHO SURGICAL Working with Regulatory Expert For FDA Filing
Fall River, MA, March 23, 2010 – NuOrtho Surgical, Inc., a developer of leading edge surgical instruments, announced it has…
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Frontier Devices received an FDA Warning Letter
Aubrey Clint Folsom, Jr. President, CEO, and Owner Folsom Metal Products, Inc. DBA Frontier Devices, Inc. 153-A Cahaba Valley Parkway…
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Stryker Says One Of Four FDA Warning Letters Now Resolved
Stryker Corp. (SYK) has resolved one of four warning letters issued by the Food and Drug Administration in recent years…
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Extremity Medical Gets CE Mark
The National Institutes of Health has announced that it is awarding 15 new grants to further develop and test the…
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Second Phase Of Patient Reported Outcomes Initiative Launched By NIH
The National Institutes of Health has announced that it is awarding 15 new grants to further develop and test the…
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BioMimetic Therapeutics Announces Positive Top-Line Data from its Augment Bone Graft North American Pivotal Trial
FRANKLIN, Tenn.–(BUSINESS WIRE)–BioMimetic Therapeutics, Inc. (NASDAQ: BMTI – News) today announced positive top-line results from its North American pivotal (Phase…
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Orthopedists Fail to Disclose Payments
Orthopedists failed to disclose over 20% of the payments they receive from makers of hip and knee replacements when presenting…
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