On August 14, 2013, the FDA issued the final guidance entitled ‘‘Radio Frequency Wireless Technology in Medical Devices: Guidance for Industry and Food and Drug Administration Staff.’’ As the FDA explains in its blog, FDAVoice, this guidance is intended to assist industry and FDA staff in identifying and appropriately addressing specific considerations related to medical devices that incorporate radio frequency (RF) wireless technology (also referred to as wireless medical devices), like Wireless Medical Telemetry Service (WMTS), Medical Device Radiocommunication Service (MedRadio), cellular communication chipsets, or RF identification (RFID) products.
Considerations for Design, Testing, and Use of Wireless Medical Devices
The guidance recommends that manufacturers take into account risks about design, testing, and use of wireless medical devices related to:
- Selection and performance of wireless technology
- Wireless quality of service
- Wireless coexistence
- Security of wireless signals and data
- EMC of the wireless technology
- Information for proper set-up and operation
Recommendations for Premarket Submissions for Wireless Medical Devices
The guidance also recommends that manufacturers incorporate into a premarket approval application for wireless medical devices the following information:
- Description of device
- Risk-based approach to verification and validation
- Test data summaries
- Labeling related to wireless medical devices
Although this FDA guidance, like guidance documents, describes the agency's current thinking on a topic and should be viewed only as recommendations, manufacturers should review their wireless medical devices in the light of this guidance to ensure that they properly account for the risks identified by the FDA, both in designing new products and preparing for the FDA premarket clearance process. In our experience, the FDA has already been applying aspects of this guidance in 510(k) submission reviews. However, with a finalized guidance document, we expect increased review times for devices incorporating wireless capability.