GOP Tries To Codify FDA’s Guidance Policy On Low-Risk Mobile Devices
This article was originally published in The Gray Sheet
Executive Summary
Republican Rep. Marsha Blackburn, Tenn., said at a July 17 House Energy and Commerce subpanel meeting on digital health she intends to codify FDA’s ‘hands off’ position for most low risk mobile medical apps and digital software, as in the mobile device guidance. But Rep. Henry Waxman, D-Calif., urged caution on putting these policies into law.