Drug & Device News

FDA Seeks Input on Oversight of Medical Apps

Because myriad medical applications for mobile devices (apps) have been put on the market, the FDA is moving to regulate some of them. To that end, the agency recently published a Draft Guidance on Mobile Medical Applications. See

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocumentsucm263280.htm
Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, explained, however, that all mobile medical apps will not be regulated by the FDA: “Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don't work as intended.” For example, things like calorie-counting apps will not be regulated, but those that are intended to work in concert with medical devices ' like an app that allows doctors to make a diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone ' will be. The FDA also plans to ensure the safety and efficacy of apps that turn mobile media into medical devices, such as those that allow smartphones to act as an ECG machine that can be used to detect when a user is experiencing a heart attack.

Suits over Plavix and AlloDerm to Receive Centralized Handling

New Jersey's Supreme Court has designated suits over two medical products for centralized case management. The suits claim damages from the use of Plavix, an anti-clotting medication used to prevent heart attacks and strokes, and AlloDerm, a surgical mesh used in skin grafts. The plaintiffs in Adkins v. Bristol-Myers Squibb Co., 07-cv-901, claim Plavix was advertised as gentler and more effective than aspirin, when in fact it was neither. According to the complaint, the FDA had to issue “numerous letters insisting these Defendants stop their misleading, over-promoting practices.” The lawsuits against Plavix manufacturers Bristol-Myers Squibb Co. and Sanofi-Aventis, and against the manufacturer of AlloDerm, LifeCell Corp, will be supervised by Middlesex County Superior Court Judge Jessica Mayer.

FDA Seeks Input on Oversight of Medical Apps

Because myriad medical applications for mobile devices (apps) have been put on the market, the FDA is moving to regulate some of them. To that end, the agency recently published a Draft Guidance on Mobile Medical Applications. See

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocumentsucm263280.htm
Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, explained, however, that all mobile medical apps will not be regulated by the FDA: “Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don't work as intended.” For example, things like calorie-counting apps will not be regulated, but those that are intended to work in concert with medical devices ' like an app that allows doctors to make a diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone ' will be. The FDA also plans to ensure the safety and efficacy of apps that turn mobile media into medical devices, such as those that allow smartphones to act as an ECG machine that can be used to detect when a user is experiencing a heart attack.

Suits over Plavix and AlloDerm to Receive Centralized Handling

New Jersey's Supreme Court has designated suits over two medical products for centralized case management. The suits claim damages from the use of Plavix, an anti-clotting medication used to prevent heart attacks and strokes, and AlloDerm, a surgical mesh used in skin grafts. The plaintiffs in Adkins v. Bristol-Myers Squibb Co., 07-cv-901, claim Plavix was advertised as gentler and more effective than aspirin, when in fact it was neither. According to the complaint, the FDA had to issue “numerous letters insisting these Defendants stop their misleading, over-promoting practices.” The lawsuits against Plavix manufacturers Bristol-Myers Squibb Co. and Sanofi-Aventis, and against the manufacturer of AlloDerm, LifeCell Corp, will be supervised by Middlesex County Superior Court Judge Jessica Mayer.