Posts Tagged ‘ substantial equivalence ’

Most High-Risk Heart Devices Approved With No Tests

Nov 25th, 2012 | By
Heart Valve rings

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 May 2012

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
510k 231 wide

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.



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

Oct 13th, 2011 | By
Dr. Rajamannan, Northwestern University

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.



How to Speed Up Approval of Medical Devices?

Oct 4th, 2011 | By
Dr. Jeffrey Shuren, CDRH

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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