FDA

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
[continue reading...]



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
[continue reading...]



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
[continue reading...]



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
[continue reading...]



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:



Want to Reclassify a Medical Device? The FDA is all Ears

Nov 15th, 2011 | By
Want to Reclassify a Medical Device? The FDA is all Ears

The Food and Drug Administration on Monday, November 14, announced it will receive public comment on whether or not a medical device should be reclassified to require more or less regulatory oversight. Share this:



FDA: Medical Device Complications Growing Faster than Industry

Nov 8th, 2011 | By
FDA: Medical Device Complications Growing Faster than Industry

Understanding Barriers to Medical Device Quality is the name of an FDA report issued October 31 by the Center for Devices and Radiological Health (CDRH) and the Food and Drug Administration (FDA) in an attempt to get a handle on why the medical device industry is putting out poorly made, defective medical devices that are
[continue reading...]



WHO ATTENDED: September 8-9 FDA Public/ Expert Meeting on Medical Devices for Obstetrics and Gynecology

Oct 4th, 2011 | By
WHO ATTENDED: September 8-9 FDA Public/ Expert Meeting on Medical Devices for Obstetrics and Gynecology

Synthetic surgical mesh has been on the hot seat of late after a July 13 FDA Safety Communication said that complications are “not rare,” a reversal from an October 2008 Public Health Notification which downplayed side effects as “rare”occurrences. Share this:



How to Speed Up Approval of Medical Devices?

Oct 4th, 2011 | By
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 that could speed up product reviews by
[continue reading...]



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.