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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October 30, 2012 ~ The FDA has issued the new rules for medical device makers to speed up the time it takes for medical devices to make it to market. Earlier this year industry agreed to pay $595 million over 5 years to the FDA as part of its operating budget. In exchange, the
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Mesh 101: The Basics For reporters looking for a way to get started on the transvaginal mesh story, here are some highlights to shortcut your research. This is not a lawyer-generated story! There are real women suffering devastating injuries from the use of plastic mesh and it continues today! “We were very shocked and
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Texas-based patient advocate, Joleen Chambers heads FIDA, FAILED Implant Device Alliance, their website is here. Chambers is interested in winning a Mayo Clinic Center for Social Media Scholarship (more here). She needs daily votes! All you have to do is add a Facebook Like or Twitter Tweet button at the bottom of each post to
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May 10, 2012 ~ ProPublica, an independent journalism organization, reports on four medical devices that are among the thousands pushed into the marketplace every year that do not undergo Food and Drug Administration (FDA) scrutiny. The bottom line – medical devices are big business bringing over $100 billion-a-year to the industry, giving industry the muscle
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MARCH 12, 2012 ~ How bad are medical devices approved by the U.S. Food and Drug Administration? Reuters reports (here) that Consumer Reports believes they are very bad. The president of the 76-year-old publication wrote in an email to 1 million subscribers this year that, “The implant that fixed your knee or your heart may
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March 7, 2012 ~ Bloomberg BNA reported (here) that the Washington Legal Foundation (WLF), had its petition rejected by the Food and Drug Administration February 21 after the industry-tied group tried to have the recommendation of an expert scientific panel barred from FDA consideration and implementation. The WLF is made up of corporate inside-the-beltway attorneys
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Medical device makers want to get their products into the marketplace faster. The U.S. Food and Drug Administration (FDA) needs more operating capital to review medical devices. The two have formed an informal agreement that was leaked to Bloomberg on Wednesday, February 1 (here). Under the proposed plan, medical device makers would pay $595 million
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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:
Artificial hips that fail, surgical mesh that injures – the New York Times reports (here) on December 14, 2011, that amid the growing number of problems with medical devices a bipartisan bill was introduced in the U.S. Senate that would require device makers follow the life of their products after they’re approved for sale. Share
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