FDA Publishes Updated Guidance on Expedited Review.  FDA recently released an updated guidance document, “Expedited Review of Premarket Submissions for Devices,” which replaces the agency’s prior guidance on the subject and reflects the changes made by the Food and Drug Administration Amendments Act of 2007 (“FDAAA”).  The new guidance is available at www.fda.gov/cdrh/mdufma/guidance/108.html.  Notably, under the new guidance, devices under expedited review from FDA will now retain that status, even if another device for the same indication is approved first.  However, any application filed after the approval or clearance of a similar device will not be granted expedited status unless necessary for reasons of national security.  Additional information is available at www.fdanews.com or www.thegraysheet.com (paid subscription service).

FDA’s Radiological Devices Advisory Panel Recommends Testing of Concurrent and Sequential Mammography CAD.  According to FDA’s Radiological Devices Advisory Panel, which met on March 4, 2008, the agency should require sponsors of computer aided detection (“CAD”) devices for mammography to test their devices with both concurrent and sequential reading approaches.  Also among the panel’s conclusions is the recommendation that sponsors should provide to FDA details of the CAD algorithm used by their device.  The panel’s recommendations will be used by the agency to develop a new guidance for industry on the FDA approval process for CAD.  Additional information is available at www.thegraysheet.com (paid subscription service).

GAO:  Reprocessed Single-Use Devices Are Safe.  According to a March 3, 2008, report issued by the Government Accountability Office (“GAO”), FDA’s approach to regulating reprocessed single-use devices (“SUDs”) is adequate to protect the public from elevated health risks.  The report states that no causal like has been established between reprocessed SUDs and reported injuries and deaths from device malfunctions.  The current safety studies of SUDs indicate that these devices pose no greater safety threat than new, non-reprocessed SUDs.  This is considered good news for device reprocessors, who point out that they represent the only segment of the U.S. device industry involved in reducing the cost of medical devices and reducing medical waste, while still providing the highest quality of medical care available.  Additional information available at www.thegraysheet.com (paid subscription service).

Device Expert Calls for More Consumer Protection.  According to William Maisel, M.D., a leading expert on medical device safety and past chairman of FDA’s Circulatory System Devices advisory panel, Congress should compel FDA and manufacturers to provide more consumer protection for patients receiving implanted devices.  According to Maisel's editorial in the March 6 issue of the New England Journal of Medicine, the welfare of medical device recipients is not a high enough priority for FDA and manufacturers.  Indeed, manufacturers have an inherent financial conflict of interest when addressing device safety issues.  Maisel has also called for FDA to balance the interests of manufacturers and patients during its review process by ensuring that every device is evaluated by an FDA reviewer specifically tasked with protecting patients’ interests.  Additional information is available at www.thegraysheet.com (paid subscription service).