FDA Heads Call For Flexible Regulatory Framework For Medical Software

Top FDA officials, including FDA Commissioner Scott Gottlieb, reaffirm the need for a new regulatory framework for software as a medical device (SaMD), which they hope will help ease the regulatory uncertainty surrounding such products, increase consumer confidence in the technology, help payers and investors understand the technology, and allow the agency to keep up with the fast pace of software development. In a Monday (July 2) article in the Journal of the American Medical Association ( JAMA ), Gottlieb,...