Posts Tagged ‘ AdvaMed ’

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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C.R. Bard Lawsuits: Rulings Reveal Company Secrets

May 23rd, 2013 | By
Bard Avaulta from website 200

May 23, 2013 ~ Buried inside some rather routine motions filed in the upcoming federal lawsuits filed in federal court in Charleston, West Virginia are some company secrets that C.R. Bard would rather keep secret. In Order #77 Plaintiffs want to take the deposition of C.R. Bard executives Roger Darois and Dan LaFever. The court
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Senate Passes FDA Funding Bill Minus Major Patient Safety Provisions

May 24th, 2012 | By
Senate on mdufa  200

May 24, 2012 ~ The U.S. Food and Drug Administration (FDA) is one step closer to being funded for the next five years in a bi-partisan vote considered good for the FDA and industry – but what about patients? The Food and Drug Administration Safety and Innovation Act passed on an unusual bi-partisan vote,  96-1,
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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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FDA Misses Deadline to File Financials for Review

Jan 24th, 2012 | By
Dr. Jeffrey Shuren, CDRH

The U.S. Food and Drug Administration (FDA) was supposed to submit a new agreement to lawmakers on  January 15, concerning how much funding it will need next year to review medical devices and conduct product reviews. Bloomberg reports (here) no new agreement was filed – the FDA essentially missed its deadline. That may hurt the
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Industry Influence – Lobbying Doesn’t Come Cheap

Dec 6th, 2011 | By
Advamed 200

AdvaMed Advanced Medical Technology Association or AdvaMed (here) calls itself the world’s largest medical technology association. In other words, it is the lobbying arm of the medical device industry and in terms of surgical mesh, there is a lot at stake.



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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Study of Medical Device Rules Is Attacked, Unseen, New York Times, July 27, 2011

Aug 14th, 2011 | By

Allies of the medical device industry criticized an Institute of Medicine report, to be released July 29, that says the approval process for a wide range of medical devices such as hip implants, hospital pumps, surgical mesh and external heart defibrillators is deeply flawed, is injuring patients and causing numerous injuries, reports the New York
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