- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological HealthOffice of Regulatory Affairs
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.*
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*
Revised: 10/1/86, 9/24/87
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-S-0610.