President Signs FDA Safety and Innovation Act
Earlier today, President Barack Obama signed into law S. 3187, the Food and Drug Administration (FDA) Safety and Innovation Act. The primary purpose of the legislation is to renew and enhance the user-fee programs for drugs and medical devices.
Among many other things, the legislation requires the FDA, Office of the National Coordinator for HIT (ONC), and the Federal Communications Commission (FCC) to develop a report detailing a “proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication” within 18 months of enactment. The legislation also authorizes the Secretary of HHS to establish a geographically diverse and balanced working group to inform the process.
An HHS press release about the legislation is now available.