substantial equivalence

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Most High-Risk Heart Devices Approved With No Tests

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 Read more

By | 2012-11-25T00:36:17+00:00 November 25th, 2012|FDA News|0 Comments

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 Read more

By | 2012-04-02T14:27:15+00:00 April 2nd, 2012|Media Reports|0 Comments

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. Read Read more

By | 2012-01-19T22:30:58+00:00 January 19th, 2012|Medical News|1 Comment

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. Read Read more

By | 2011-10-13T01:11:50+00:00 October 13th, 2011|Featured|3 Comments

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 Read more

By | 2011-10-04T03:01:12+00:00 October 4th, 2011|FDA News|0 Comments