FDA still aims to finalize a draft guidance on mobile medical applications by the end of the year, CDRH policy advisor Bakul Patel told “The Gray Sheet” recently. But guidance on related medical software, including clinical decision support tools, electronic medical records and health information technology, is proving more complex and will likely take longer, he suggested.
Patel and other agency officials spoke Sept. 20 at an FDA user fee update meeting hosted in Washington, D.C., by the Food and Drug Law Institute and the Drug Information...