FDA Guidance Document for
Galvanic Skin Response Measurement Devices


Biofeedback is a relaxation technique that can help people learn to control various autonomic functions. In biofeedback, the patient is wired to a device that continuously signals the heart rate, degree of muscle contraction, skin resistance, or other indicator. The patient is instructed to relax so that the signals decrease to a desirable level. The patient may ultimately learn to control the body function subconsciously without the machine.

In 1994, the FDA issued a document to guide the approval process for devices used to measure skin resistance. These devices—commonly referred to as galvanic skin response or GSR devices—produce a tiny current and measure how well the current passes from the skin back to the device. The main factor that influences the GSR is perspiration. (Electrical current passes readily through water, perspiration will lower the GSR). GSR devices have legitimate use in relaxation treatment but no legitimate use for diagnosis or to influence any disease process.

The document below, which is slightly reformatted from the original to make it more readable, provides manufacturers with guidance about what is needed to get FDA "510(k)" clearance for marketing. It appears to have been issued to prevent manufacturers of quack diagnostic and treatment devices from getting 510(k) clearance as "biofeedback" devices, which they are not. The electrodes of legitimate biofeedback devices are temporarily affixed to the patient's skin so that the pressure against the skin remains constant. With most quack devices, one electrode is a probe that the operator touches to patient's skin with variable pressure that influences what the device measures.


U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Devices and Radiological Health
Rockville, MD 20850

Neurological Devices Branch
Division of Cardiovascular, Respiratory and Neurological Devices
Office of Device Evaluation
August 1994

Skin Response Measurement Devices - Draft Guidance For 510(K) Content

INTRODUCTION

This guidance is to be used in conjunction with the Division of Cardiovascular, Respiratory and Neurological Devices "Draft Guidance for Format and Content for Premarket Notification 510(k)", which provides general guidance for preparing a "510(k)" premarket notification. Its purpose is to provide specific applicable to 510(k)s that claim equivalence to Galvanic Skin Response measurement (GSR) devices.

I. BASIC DESIGN DESCRIPTION

II. COMPARATIVE DEVICE SPECIFICATIONS

III. INDUSTRY STANDARDS

IV. TEST DATA

V. LABELING

___________________

This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP's.

This guidance document may contain references to addresses and telephone numbers that are now obsolete. The following contact information is to be used instead:

REFERENCES

  1. "Connection of Electrode Lead Wires to Line Power,"Health Devices, Emergency Care Research Institute, pp.44-46, Feb. 1987.
  2. "Risk of Electric Shock from Patient Monitoring Cables and Electrode Lead Wires,"Health Devices, Emergency Care Research Institute, pp.301-303.
  3. "FDA Public Health Advisory: Unsafe Electrode Lead Wires and Patient Cables Used With Medical Devices," December 28, 1993.
  4. American National Standard, Safe Current Limits for Electromedical Apparatus ANSI/AAMI ES1 1985. Association for the Advancement of Medical Instrumentation, 1901 North Fort Meyer Drive, Suite 602, Arlington, Virginia 22209.
  5. Standard for Medical and Dental Equipment—UL 544, Second Edition 1976, (Reprinted May 21, 1992), Underwriters Laboratories, Inc., 333 Pfingsten Road, Northbrook, Illinois 60062.
  6. "Reviewer Guidance for Computer Controlled Medical Devices," Center for Devices and Radiological Health, August 29, 1991.

This article was posted on November 2, 2004.

Links to Recommended Companies