Posts Tagged ‘ CDRH ’

FDA Workshop on Health of Women

Apr 9th, 2013 | By

April 9, 2013 ~ According to a new page on the FDA’s website (here), a public workshop will be held on HoW to Improve the Health of Women (HoW).  The purpose is to delve into how some medical devices work differently in women than men. It’s been noted that some hip implants have an early
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FDA Whistleblower Case Moving Ahead

Nov 13th, 2012 | By
FDA Whistleblower Case Moving Ahead

November 13, 2012 ~Round one in the FDA whistleblower scandal goes to the U.S. Food and Drug Administration. Regulatory Focus (here) reports the FDA had a minor victory November 9, in its case against the National Whistleblower Center (NWC) which is representing five both current and former employees of the FDA who claim they were
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FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

Jun 14th, 2012 | By
FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

If you ask the public, most say they want safer medical devices, not more of them.  If you ask the patients profiled in Mesh Device News Desk (MDND) they’d say they wished they’d known that the medical devices they received had come with a prominent warning that would have told them what they were in
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Sen. Grassley Comes to Defense of One Whistleblower in Letter to Hamburg

Feb 8th, 2012 | By
Sen. Grassley Comes to Defense of One Whistleblower in Letter to Hamburg

February 9, 2012 ~ “Whistleblowers point out fraud, waste and abuse when no one else will, and while they do so while risking their professional careers, they are often treated like skunks at a picnic,” Grassley wrote. “Whistleblowers have played a critical role in exposing harmful government actions and retaliation against whistleblowers should never be
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FDA Whistleblowers Sue Agency, Claim Retaliation Over Unsafe Medical Device Revelations

Jan 30th, 2012 | By
FDA Whistleblowers Sue Agency, Claim Retaliation Over Unsafe Medical Device Revelations

January 30, 2012 ~ What’s going on inside the FDA? Six of the “FDA Nine” whistleblowers are suing the agency for illegally spying on their private email claiming they were retaliated against after they warned lawmakers that unsafe medical devices were being approved for market.  You may recall as President Obama was taking office on
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Toys from China and Medical Devices Share Scrutiny in EU

Jan 27th, 2012 | By
Toys from China and Medical Devices Share Scrutiny in EU

Many in the United Kingdom assume that an implanted medical device is reviewed for safety before it is permanently placed inside a patient. They would be wrong. The Guardian reports (here) that the European quality standard – the CE mark – represents an assurance that is the same whether the product is a breast implant
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FDA: Medical Device Complications Growing Faster than Industry

Nov 8th, 2011 | By
FDA: Medical Device Complications Growing Faster than Industry

Understanding Barriers to Medical Device Quality is the name of an FDA report issued October 31 by the Center for Devices and Radiological Health (CDRH) and the Food and Drug Administration (FDA) in an attempt to get a handle on why the medical device industry is putting out poorly made, defective medical devices that are
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How to Speed Up Approval of Medical Devices?

Oct 4th, 2011 | By
How to Speed Up Approval of Medical Devices?

OCTOBER 3, 2011 -  How to speed up the approval of a medical device that cannot claim it is substantially similar to one already on the market under 510(k)? On Friday, September 30, the Food and Drug Administration released a long-awaited proposed revision to the 510(k) clearance process that could speed up product reviews by
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Former FDA Director Joins Consulting Company as President, Market Watch, September 14

Sep 14th, 2011 | By

Is this the revolving door? Ron Johnson, former Director of the Office of Compliance within the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA), has taken a job as President of BECKER CONSULTING, according to a press release on Market Watch.  According to the release, Mr. Johnson spent
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Push to More Regulation Heats Up FDA Expert Panel on Surgical Mesh

Sep 9th, 2011 | By
Push to More Regulation Heats Up FDA Expert Panel on Surgical Mesh

SEPTEMBER 8, 2011 – About the only thing that the room full of injured patients, industry representatives, and surgeons could agree on at the first FDA hearing on synthetic surgical mesh was that more studies are needed on the safety and efficacy of the controversial medical device. This was the first of a two-day expert
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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.