FDA guidance document on RF Wireless Technology in Medical Devices

With the growing use of incorporating wireless technology into medical devices, the FDA has issued a final guidance Radio Frequency Wireless Technology in Medical Devices. This guidance document is meant to cover a wide range of medical devices that use wireless technology from imaging and systems used in a hospital or clinical setting to devices implanted or applied directly on the patient's body. The guidance document recommends certain design control and testing measures as well as post-market maintenance monitoring that can be taken in order to ensure safety to the patient.

The interesting thing about RF Technology is that it involves FCC regulations not just the FDA when it is implemented into a medical device. Because of this, both governing bodies have requirements that need to be considered when designing a medical device with this type of technology. The positive thing about this guidance document was that the FDA did have communication with the FCC in its formulation. However both sets of regulations from the FDA and FCC still need to be reviewed and considered throughout the life-cycle of the device.

The FDA has written a blog post about the issuance of the final guidance document and how it is an important document because of the growing use of wireless technology in the medical device industry.

Additionally there have been other articles written about the FDA issuing this guidance document explaining the various important points within the guidance document. For example this post by Tim Gee goes into detail different sections of the guidance document. It was interesting to read through this interpretation of the guidance document.

Wireless technology is definitely a hot topic and fully analyzing and understanding how it impacts the end user is an important issue to address.

--Jillian F. Walker