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fda regulations
fetal ultrasound doppler

The FDA regulates all the different types of ultrasound . Each form or use of ultrasound is regulated differently. The following regulation is for a class II device which includes the fetal doppler ultrasound monitor.

The FDA permits the use of medical grade fetal dopplers for patients at home with a physicians approval.

The FDA regulates fetal ultrasound dopplers. Not all fetal dopplers on the market are approved by the FDA. Be sure your doppler is approved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=884.2660

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 884 -- OBSTETRICAL AND GYNECOLOGICAL DEVICES

Subpart C -- Obstetrical and Gynecological Monitoring Devices

Sec. 884.2660 Fetal ultrasonic monitor and accessories.

(a) Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.

(b) Classification. Class II (performance standards).
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