Posts Tagged ‘ Institute of Medicine ’

The 510(k) Process – Safety Forgotten

Jan 23rd, 2014 | By

THE 510(k) PROCESS – SAFETY FORGOTTEN By Dan C. Bolton, Of Counsel, Keller, Fishback & Jackson LLP The 510(k) process is relied upon by the medical device industry, including pelvic mesh manufacturers, such as Ethicon/Johnson & Johnson, Atrium Medical Corporation, and Davol/Bard, to quickly get devices marketed in the United States.  (The term “510(k)” is
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FDA Considers Revising 510(k), Industry Balks

Jun 13th, 2013 | By
FDA logo  2  200

June 13, 2013~ “External stakeholders.” That is what the FDA calls medical device manufacturers who also  have a decisive role in shaping the regulations they fall under. Thursday, June 13, the FDA met with stakeholders to discuss modifying the 510(k) approval process. (here) About 90 percent of the 4,000 medical devices approved by the FDA
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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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FDA Follows Industry Lead to Shorten Time to Market

Oct 31st, 2012 | By
2 TYPES OF HIP  replacement total and resurfacing

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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Reporters Resource on Covering Mesh Issues

Aug 31st, 2012 | By
Surveillance 200 wide

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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Patient Advocate Joleen Chambers Needs Your Vote!

Jul 17th, 2012 | By
Joleen Chambers

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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ProPublia: Four Medical Devices that Bypassed FDA Scrutiny

May 10th, 2012 | By
Mesh after removal

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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Consumer Reports Campaign email Alerts Million About Defective Medical Devices

Mar 13th, 2012 | By
Consumers Union Safe Patient project logo 218

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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FDA Denies Legal Group Seeking to Ban IOM Recommendations

Mar 8th, 2012 | By
WLF

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 Will Double Fees for Faster FDA Reviews

Feb 1st, 2012 | By
Mesh medical device after removal

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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