FDA ADDRESSES USE OF RADIO-FREQUENCY WIRELESS TECHNOLOGY IN MEDICAL DEVICES
When designing medical devices that use radio-frequency (RF) wireless technology, firms should consider how those products will interact with other devices and respond to potential electromagnetic interference, the FDA says in new draft guidance.
The guidance, published Jan. 3, includes recommendations on risk management, testing, labeling, purchasing controls and servicing for RF wireless technologies that include:
Devices covered by the FCC's Part 15 rule;
Devices covered by the Wireless Medical Telemetry Service (which allows potentially life-critical equipment to operate on an interference-protected basis);
Cellular phones;
Handheld computers and personal digital assistants;
Local area networks,
Laptop computer modems;
Personal area networks such as Bluetooth, ultrawide band and Zigbee; and
RF identification.
Risk management should be part of the design and development phases for devices that include RF wireless technologies, the guidance says. A key factor in the safety and effectiveness of such devices is "the limited amount of RF spectrum available and potential competition among wireless technologies for the same spectrum," the guidance says.