The Federal Communications Commission and FDA signed a memorandum of understanding (MOU), agreeing that that the agencies will work together to create an efficient regulatory structure for wireless-enabled medical devices and services. The agreement has a five-year sunset provision built into it.
The FCC and FDA have four key goals for the collaboration, as follows:
- Further enhance information sharing efforts in order to further ensure the safety and efficacy of medical devices.
- Improve the efficiency of the agencies’ regulatory processes in areas where their jurisdiction overlaps, such as with respect to various medical devices that utilize broadband and wireless technology.
- Promote efficient utilization of tools and expertise for product analysis, validation, and risk identification.
- Build infrastructure and processes that meet the common needs for evaluating broadband and wireless enabled medical devices.
Read the full text of the MOU here (PDF)