FDA issues draft guidance for wireless medical devices

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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. The agency stated that wired medical devices are reliable than wireless one. However, we’re moving to a wireless world if we’re not there already. To guarantee that wireless devices are safe for use, the draft guidelines are looking are a number of key areas of concern, such as:

  • How radio frequency (RF) wireless emissions from one product or device can affect the function of another;
  • Evaluating how electromagnetic environments where medical devices are used may contain many sources of RF energy and the implications of that; and
  • How the use of RF wireless technology in and around medical devices is on the upswing.

"These issues involve all stages of the product life cycle and should be considered in preparing premarket submissions," the FDA said.

The "Draft Guidance for Industry and FDA Staff; Radio-Frequency Wireless Technology in Medical Devices" can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/06d-0504-gdl0001.pdf or http://www.fda.gov/cdrh/osel/guidance/1618.html

The agency is accepting written or electronic comments on the draft guidance until April 3. Visit: http://www.fda.gov/dockets/ecomments