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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 Draft Guidance for Radio-Frequency Wireless Technology in Medical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U.S. Food and Drug Administration (FDA) issued draft guidance for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
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Wireless coexistence
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Performance
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Data Integrity
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Security
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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
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