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:

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
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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:

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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CNN reports on MelaFind, a handheld medical device that helps doctors spot melanoma using a noninvasive computer imaging.  But it is still not approved by the Food and Drug Administration, and may not be.  The agency refused to take the next step to approval in 2009, even though the machine was on the fast-track. Uncertainty
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AUGUST 31, 2011 /If a U.S. Food and Drug Administration (FDA) staff report is adopted, synthetic surgical mesh manufacturers such as Boston Scientific Corp., Johnson & Johnson, American Medical Systems and six other makers of  mesh used for pelvic organ prolapse (POP) repair may be forced to submit safety data to keep their products on
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When you have a new car that develops a “safety” issue i.e. braking, steering, airbags, wiring, engine cooling, unintended acceleration etc, the auto dealer reports the problems to the manufacturer, who by law, must report the issue to the National Highway Traffic Safety Administration within five days. But when a patient has a problem with
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This August 26, 2011 blog on Gateway FDA is written for the medical device industry and its lawyers. The FDA recently issued new draft guidelines so manufacturers understand how to comply with the controversial 510(k) fast-track approval for marketing of their medical device. The new guidelines replace the 1997 guidelines for 510(k) submission. Included is
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This excellent article by Morningstar reminds us that the Food and Drug Administration (FDA) has been reviewing the regulatory process that allows most medical devices to make their way into the marketplace and the agency plans to have new changes in place by October. This is sparked by the July release of the Institute of
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The FDA is pushing back on an Institute of Medicine recommendation that the fast-track approval process for medical devices is fatally flawed and should be replaced, reports Reuters. FDA’s Jeffrey Shuren, director of the Center for Devices and Radiological Health, which oversees devices, said the 510(k) process should not be eliminated, but “we are open
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