Mar 11, 2011
At a US Food and Drug Administration town hall meeting held March 10 in Irving, TX, Center for Devices and Radiological Health director Dr. Jeffrey Shuren disclosed to Emergo Group officials in attendance that the regulator plans to issue guidance on mobile medical applications later this year. Manufacturers have thus far received little official guidance from the FDA regarding how the CDRH would handle mobile medical applications. Although some medical devices incorporating mobile applications have already been cleared by the FDA—GE’s Pocket Viewer, Airstrip Technologies’ Airstrip, Mobisante’s MobiUs and MIM Software’s Mobile MIM, for example—no high-level evaluation criteria have yet been issued by the regulator regarding these products. According to information provided by FDA officers at the town hall, software validation will be required for mobile medical applications. Whether such devices would have to go through 510(k) or pre-market approval processes, or be ruled 510(k)-exempt—has not yet been determined, they said. As mobile application and medical device technologies will only converge at a steadier rate going forward, the FDA’s pending guidance on this industry-changing trend should prove highly influential in both how manufacturers devise mobile capabilities and how other regulators develop their own approaches to such devices.
A new study sponsored by the US medical device industry trade association Advanced Medical Technology Association (AdvaMed), “EU Medical Device Approval Safety Assessment,” has found that the European regulatory system has performed just as effectively in terms of public safety as the US Food and Drug Administration while simultaneously providing a speedier and more efficient path to market for manufacturers.
Business-friendly US lawmakers and the FDA’s Center for Devices and Radiological Health director Dr.
Through new guidance published this month, the US Food and Drug Administration has clarified its review and approval process for its Investigational Device Exemption (IDE) regulations, and has also proposed steps to allow clinical investigations of high-risk medical devices in some instances where IDE approvals have not been finalized.