2007 Kick off – FDA Provides Draft Guidance for Industry & FDA Staff: RF Wireless Technology in Medical Devices

RFID Law Journal
Newsletter No. 36
January 7, 2007

On January 3rd, the FDA released for public comment purposes only a draft document on radio frequency wireless technology in medical devices. The FDA published this document to guide stakeholders in the development and evaluation of RF wireless technology with respect to medical devices. The rationale is providing guidance on the safe and effective use of RF wireless technology in medical devices (e.g., performance, data integrity, security, etc.). Among other things, the draft document provides examples of potentially problematic applications. The FDA provides recommendations, including consideration of issues in product design requirements, design verification and validation, and risk management processes.

You’re invited to learn more at the FDA link: http://www.fda.gov/cdrh/osel/guidance/1618.html. During the 90 day public comment period, the FDA invites questions through Donald M. Witters, Jr. at donald.witters@fda.hhs.gov. Interest parties may provide comments on the draft guidance document at: http://www.fda.gov/dockets/ecomments.

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