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In this section: Guidance Documents (Medical Devices and Radiation-Emitting Products)

Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient Cables - Guidance for Industry and FDA Staff

Read the Special Controls Document

Issue Date: 11/15/1999

Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health

This level 2 guidance concerns the applicability of the Performance Standard for Electrode Lead Wires and Patient Cables (Code of Federal Regulations, Chapter 21, Part 898) to active leads used with electrosurgical devices.

The performance standard was established to prevent unintended electrical connections between patients and electrical power sources. The performance standard applies to electrode lead wires and patient cables intended for use with a medical device.

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