BACKGROUND:
The Food and Drug Administration has in the past advised distributors of blood pressure
measuring devices (sphygmomanometers) that such devices should be distributed only under
the prescription legend. Some imported devices have been detained for failure to bear the
legend. This was based on the opinion of our medical advisers that a blood pressure
reading requires interpretation and evaluation by a physician in order to have any real
significance.
*The status of such devices has been reviewed and it is now apparent that, although
medical opinion could be obtained regarding the advisability of a prescription legend on
sphygmomanometers, we do not now have evidence of injury or hazard to health resulting
from lay use of these devices.*
POLICY:
We are not prepared to initiate regulatory action based solely on the lack of the
prescription legend on sphygmomanometers.
*Material between asterisks is new or revised*
Issued: 1/1/73
Revised: 10/1/86, 9/24/87