A bill recently introduced into the House of Representatives would provide regulatory clarity regarding mobile apps, clinical decision support, electronic health record systems and other medical software.
The Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, introduced by Reps. Marsha Blackburn (R-Tenn.), Gene Green (D-Texas), Phil Gingrey (R-Ga.), Diana DeGette (D-Colo.), Greg Walden (R-Ore.) and G. K. Butterfield (D-N.C.), builds on the regulatory guidance recently released by the Food and Drug Administration to develop a framework to help ensure patient safety while encouraging innovation.
“This bill would provide the FDA with the tools it needs to effectively protect consumers who use high risk technologies, while allowing the innovation of low risk technologies to continue without being caught up in the expensive and time-consuming FDA approval process all while protecting patient safety,” said Rep. Blackburn in a news release.
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