“Given the proliferation of medical devices using wireless technology — and the accompanying risks regarding security, performance, compatibility, and other challenges — FDA in August 2013 issued a guidance for radio frequency wireless technology in medical devices,” write Michael D. Shalhoub and Soo-young Chang, attorneys in Goldberg Segalla’s Life Sciences and Cyber Risk and Social Media Practice Groups.
“Although the guidance states that it is only a recommendation and does not establish legally enforceable responsibilities, it is nonetheless useful for device makers. Guidances provide FDA’s interpretation of existing regulations and are frequently referenced by attorneys and courts in lawsuits seeking to establish that a manufacturer was negligent for failing to follow FDA statements in a guidance. Review of the wireless technology guidance, therefore, is critical for companies whose devices use such technology.”
This article examines FDA’s guidance regarding design, testing, and use of wireless technology, as well as its recommendations for premarket submissions for devices that incorporate radio frequency wireless technology.