Posts Tagged ‘ substantial equivalence ’

Most High-Risk Heart Devices Approved With No Tests

Nov 25th, 2012 | By
Most High-Risk Heart Devices Approved With No Tests

November 24, 2012 ~  Most readers of Mesh Medical Device News Desk are familiar with the ease with which surgical mesh and other medical devices make it to the market. An exchange of paperwork and a claim of ‘substantial equivalence’ to another device already being sold, and a manufacturer can launch his product- even a
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Consumer Reports: Dangerous Medical Devices

Apr 2nd, 2012 | By
Consumer Reports: Dangerous Medical Devices

April 1, 2012 ~ The May issue of Consumer Reports (here)  features an investigation into synthetic mesh and artificial hips – medical devices that escape rigorous testing to assure safety. Tens of millions of Americans are living with medical devices and whether a defibrillator, artificial hip or surgical mesh, – 90 percent of those devices
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New England Journal of Medicine – Medical Devices – Balancing Regulation and Innovation

Jan 19th, 2012 | By
New England Journal of Medicine – Medical Devices – Balancing Regulation and Innovation

January 19, 2012 ~ In a letter to the Editor of the New England Journal of Medicine (NEJM), (here) January 19, 2012, Neil Feder, M.D. of the Project on Government Oversight writes about the 510(k) process that allows untested medical devices onto the market without premarket approval. Share this:



Money and Medical Devices – Not Even a Whistleblower Can Stand in the Way

Oct 13th, 2011 | By
Money and Medical Devices – Not Even a Whistleblower Can Stand in the Way

OCTOBER 12, 2011 – MassDevice (here) reports on the firing of Dr. Nalini Rajamannan, an associate professor of medicine at Northwestern University, who blew the whistle on a fellow physician for failing to obtain consent from patients before implanting an experimental medical device he invented. Share this:



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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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.