FDA

Johnson & Johnson Began Phasing out DePuy Defective Hip Prior to Recall

Mar 23rd, 2012 | By
Johnson & Johnson Began Phasing out DePuy Defective Hip Prior to Recall

March 23, 2012 ~ This has not been a good week for Johnson & Johnson. First word that it sold the transvaginal surgical mesh, ProLift, without getting any sort of FDA approval in advance (see background story here). Now the New York Times (NYT) (here) is reporting that J&J began phasing out the DePuy defective
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Survey: Despite Progress, FDA Scientists Feel Political and Industry Pressure

Mar 14th, 2012 | By
Survey: Despite Progress, FDA Scientists Feel Political and Industry Pressure

March 7, 2012 ~ The Union of Concerned Scientists (USC) issued the results of a survey released today of 977 Food and Drug Administration scientists. They were asked about the pressure they feel to approve drugs and medical devices – can they communicate candidly with the public? – can they publish their results? –  is
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Australia’s Version of FDA Lax on Medical Device Safety

Mar 6th, 2012 | By
Australia’s Version of FDA Lax on Medical Device Safety

With the global news about the defective French breast implants called PIP filled with industrial silicone, the Canberra Times (here), published in the capital city of Australia, takes a look at how medical devices reach the market there. Australia’s version of the U.S. Food and Drug Administration (FDA) is called the Therapeutic Goods Administration (TGA)
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FDA: What is MDUFA? Hearings on $595 Million and What Industry Wants

Feb 14th, 2012 | By
FDA: What is MDUFA? Hearings on $595 Million and What Industry Wants

February 14, 2012 ~ What is MDUFA? The Medical Device User Fee and Modernization Act shortened from MDUFMA. Enacted in 2002 and again in 2007 it authorized the FDA to collect a user fee from industry to review medical devices before they go on sale. MDUFA in 2010 funded about 20 percent of the medical
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Where Are the Postmarket Surveillance Plans for POP, SUI Mesh?

Feb 14th, 2012 | By
Where Are the Postmarket Surveillance Plans for POP, SUI Mesh?

February 14, 2012 ~ Where’s the Plan? On January 3, 2012, the FDA sent out copies of a 522 order to 33 manufacturers of synthetic surgical mesh for pelvic organ prolapse and 7 manufacturers of mesh for stress urinary incontinence. Here is the background story on MDND. The request says, “Within 30 days of receipt
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Mesh Makers Who Received FDA Letter Requiring Postmarket Surveillance

Jan 9th, 2012 | By
Mesh Makers Who Received FDA Letter Requiring Postmarket Surveillance

JANUARY 9, 2012 ~ The following is a list of the companies who received the letters from the Food and Drug Administration (FDA) January 3, 2012, requesting three years of followup studies on the complications associated with synthetic surgical mesh used for pelvic organ prolapse and stress urinary incontinence. This is unprecedented in that the
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More Monitoring of Medical Device Implants After Market

Dec 18th, 2011 | By
More Monitoring of Medical Device Implants After Market

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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FDA and Med Device Makers Make it Official

Dec 8th, 2011 | By
FDA and Med Device Makers Make it Official

by Jane Akre// DECEMBER 7, 2011 //Shuren Signs Memo of Understanding// Minnesota loves its medical device industry. Even Senator Al Franken (D-MN) who used to parade on Saturday Night Live with a satellite dish on his head as a roving comedic newsman, has gotten pretty serious when it comes to promoting legislation to help Minnesota’s
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FDA: Recalled Medical Devices for 2011

Dec 6th, 2011 | By

The FDA announced its Recalled Medical Devices for 2011 December 6th, Tuesday. The Recall Classifications are divided into three classes according to the potential level of hazard. Share this:



Can the FDA Promote Innovation and Protect Patients?

Nov 17th, 2011 | By
Can the FDA Promote Innovation and Protect Patients?

CDRH Shuren Defending FDA Against Harsh Industry Critics Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), was on the hot seat Share this:



We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.