The FDA has released its final guidance that outlines an approach to regulating the fast growing and ever evolving category of medical devices that employ radiofrequency wireless technology (RF). The guidance, which was issued on August 13, 2013, comes more than six years after the original draft guidance was issued in January 2007.
Market reports indicate that more companies are relying on RF technology, so the guidance addresses its safe and effective use, which includes:
- Wireless medical telemetry service
- Medical device radio communication service
- Medical body-area-network
- Cellular communications chipsets and;
- RF identification products
The guidance also provides recommendations for information to be included in FDA pre-market submissions for devices.
Bakul Patel, a senior policy analyst in CDHR’s Office of the Center Director explained that the final guidance was delayed because FDA wanted to ensure its policy could withstand the technology iterations that were occurring in the RF wireless technology field at that time. The FDA has emphasized to manufacturers that they need to address know safety issues involving RF technology early in the device design and development process.
Overall, the FDA has increased its focus on the growing wireless devices market. This June, the agency also released a draft guidance on cybersecurity submission standards for devices with embedded computer systems.
What are your thoughts on RF technology and the FDA’s final guidance document? Please share you thoughts below.
Photo Credit: abdullah.khan2012