FDA proposed rule aims to simplify medical app classification
A proposed rule from the FDA amends the agency's regulations governing classification and reclassification of medical devices to conform to provisions in the FDA Safety and Innovation Act (FDASIA), simplifying the classification process.
"FDA is proposing these revisions to update its regulations to reflect these and other changes, and to ensure classification of devices in the lowest regulatory class consistent with the protection of the public health and the statutory scheme for device regulation," the proposed rule reads.Congress passed FDASIA in 2012 to change the procedures for reclassification of devices under the Federal Food, Drug and Cosmetic Act, and to reduce some of the bureaucratic red tape associated with the classification process.
The FDA issued its final guidance on mobile apps last September, focusing its oversight on high-risk mobile medical apps. This proposed rule comes on the heels of a bipartisan group of senators' request for further clarity and transparency from the FDA regarding its mobile medical apps policy.
The public comment period for the proposed rule ends June 23.
Editor Beth earned a bachelor’s degree in journalism and master’s in health communication. She has worked in hospital, academic and publishing settings over the past 20 years. Beth joined TriMed in 2005, as editor of CMIO and Clinical Innovation + Technology. When not covering all things related to health IT, she spends time with her husband and three children.