FDA ISSUES GUIDANCE ON WIRELESS TECHNOLOGY IN MEDICAL DEVICES

The FDA Jan. 3 issued guidance on the use of radio-frequency wireless technology in medical devices. The guidance covers wireless coexistence, performance, data integrity, security and electromagnetic compatibility.

"These issues involve all stages of the product life cycle and should be considered in preparing premarket submissions," the FDA said. The agency is accepting written or electronic comments on the draft guidance until April 3.

The "Draft Guidance for Industry and FDA Staff; Radio-Frequency Wireless Technology in Medical Devices" can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/06d-0504-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0504-gdl0001.pdf).