April 9, 2013 ~ According to a new page on the FDA’s website (here), a public workshop will be held on HoW to Improve the Health of Women (HoW). The purpose is to delve into how some medical devices work differently in women than men. It’s been noted that some hip implants have an early
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March 29, 2013 ~ In September 2011, the U.S. Food and Drug Administration convened a panel of experts to try and get a handle on the concerning number of complications the agency was receiving about surgical mesh used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The experts suggested that because of the
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December 4, 2012 ~ The FDA will collaborate with the medical device industry it regulates in a public-private collaboration, all to speed up the approval of new devices. The newly formed nonprofit group, Medical Device Innovation Consortium (MDIC), has a goal of speeding up and simplifying the design and testing of medical devices, reports CBS
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November 26, 2012 ~ The U.S. Food and Drug Administration (FDA) is a large public agency that regulates consumer products that make up about $1 trillion in annual spending or 25 cents of every dollar spent on food, cosmetics, drugs, medical devices and tobacco products. The Partnership for Public Service supported by the Pew Charitable
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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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November 13, 2012 ~Round one in the FDA whistleblower scandal goes to the U.S. Food and Drug Administration. Regulatory Focus (here) reports the FDA had a minor victory November 9, in its case against the National Whistleblower Center (NWC) which is representing five both current and former employees of the FDA who claim they were
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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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September 19, 2012 ~ Last January, after a five-fold increase in complications was noted by the U.S. Food and Drug Administration (FDA) concerning synthetic mesh used in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the FDA ordered mesh makers to find out why. At the time, the unprecedented request was
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Public Invited to FDA meeting on Postmarket Surveillance September 4, 2012~ Every modern day vehicle comes complete with a VIN number, an identifier number that stays with the car during its lifetime. If there is an auto recall the owner is notified and an auto dealership can easily identify a vehicle that might fall under
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August 7, 2012 ~ This item apparently bypassed the desk of MDND. Last month, Deputy Director of the FDA’s Center for Devices and Radiological Health, Dr. William Maisel, was reportedly arrested in a prostitution sting operation in Maryland, according to MassDevice (here). According to the case report here , Dr. Maisel, 46, was arrested on
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