[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.1735]

[Page 361-362]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 876.1735  Electrogastrography system.

    (a) Identification. An electrogastrography system (EGG) is a device 
used to measure gastric myoelectrical activity as an aid in the 
diagnosis of gastric motility disorders. The device system includes the 
external recorder, amplifier, skin electrodes, strip chart, cables, 
analytical software, and other accessories.
    (b) Classification. Class II (Special Controls). The special 
controls are as follows:

[[Page 362]]

    (1) The sale, distribution and use of this device are restricted to 
prescription use in accordance with Sec. 801.109 of this chapter.
    (2) The labeling must include specific instructions:
    (i) To describe proper patient set-up prior to the start of the 
test, including the proper placement of electrodes;
    (ii) To describe how background data should be gathered and used to 
eliminate artifact in the data signal;
    (iii) To describe the test protocol (including the measurement of 
baseline data) that may be followed to obtain the EGG signal; and
    (iv) To explain how data results may be interpreted.
    (3) The device design should ensure that the EGG signal is 
distinguishable from background noise that may interfere with the true 
gastric myoelectric signal.
    (4) Data should be collected to demonstrate that the device has 
adequate precision and the EGG signal is reproducible and is 
interpretable.

[64 FR 51444, Sept. 23, 1999]