FDA's Bakul Patel: For mobile medical apps, patient safety first

by Greg Slabodkin, FierceMobileHealthcare As Senior Policy Advisor to the Director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration, Bakul Patel (pictured right) advises the Center Director on regulatory policy issues related to medical device software and systems, health information technology, and mobile health. In fact, Patel is the primary author of the FDA's draft guidance for mobile medical applications that the agency issued in July 2011. However, the FDA has come under fire from critics, including Congress, for being slow to finalize the agency's draft guidance for mobile medical apps. In addition, critics charge that the July 2011 draft FDA guidance on mobile medical apps remains unclear and unpredictable. Without clear guidance, app developers say they don't know whether they should pursue certification of their products as medical devices, sidestep the process altogether and jump into product development or wait for the FDA to issue its final guidance, which is now expected by the end of fiscal 2013. FierceMobileHealthcare spoke with Patel about the FDA's regulatory oversight and review of mobile medical apps as the agency continues to finalize its guidance. To learn more, read the full interview at FierceMobileHealthcare.
Source: hospital impact - Category: Health Managers Authors: Source Type: blogs