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 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 28, 2012 ~ Working with undercover reporters from The Daily Telegraph in the UK, the British Medical Journal’s (BMJ) Deborah Cohen has exposed, “a fragmented, poorly regulated, market driven system, with financial incentives to prioritize manufacturers’ interests over those of patients, and with no requirement for clinical evaluation of a device’s safety or effectiveness,”
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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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March 20, 2012 ~ The advocacy group, Public Citizen in a letter (here) to Congress issued Monday, March 19 calls on the U.S. House to Reject the medical liability bill called H.R. 5. The House may vote this week on the legislation called the Help Efficient, Accessible, Low-Cost, Timely Healthcare Act. It essentially shields the
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February 9, 2012 ~ “Whistleblowers point out fraud, waste and abuse when no one else will, and while they do so while risking their professional careers, they are often treated like skunks at a picnic,” Grassley wrote. “Whistleblowers have played a critical role in exposing harmful government actions and retaliation against whistleblowers should never be
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January 23, 2012 ~ House Democrats are asking Republicans for a hearing on Johnson & Johnson synthetic surgical transvaginal mesh used to treat pelvic organ prolapse, and the Allergan Lap-Band for weight reduction because of a growing number of patient injuries and a fear that device makers and the U. S. Food and Drug Administration
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January 19, 2012 ~ In a letter to the Editor of the New England Journal of Medicine (NEJM), (here) January 19, 2012, Neil Feder, M.D. of the Project on Government Oversight writes about the 510(k) process that allows untested medical devices onto the market without premarket approval. Share this:

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: