Draft Guidance for Radio-Frequency Wireless Technology in Medical Devices

January 3, 2007 Draft Guidance for Radio-Frequency Wireless Technology in Medical Devices U.S. Food and Drug Administration (FDA) issued draft guidance for issues and concerns about the safe and effective use of radio frequency wireless technology in medical devices. The issues addressed include Wireless coexistence  Performance  Data Integrity  Security  Electromagnetic compatibility The FDA encourages device manufacturers to consider these issues at all stages of product lifecycles. Special attention should be paid in the pre-market phase to identification, documentation, and implementation of product design requirements, design verification and validation, and risk management processes and procedures . . .