- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological HealthOffice of Regulatory Affairs
*The Federal Food, Drug, and Cosmetic Act (the Act), section 502(f)(1), provides that the labeling of a device shall bear adequate directions for use unless exempted from this requirement by regulation. 21 CFR 801.109 provides an exemption in the case of those devices which cannot be safely and efficaciously used except under medical supervision.*
A physician must determine the size and type of diaphragm for the patient. For proper results the device must be placed by the physician and inspected at intervals to avoid injury to the patient.
Diaphragms are devices which shall be distributed by prescription only. Any diaphragm that fails to bear the prescription legend is misbranded under *section 502(f)(1) of the Act.*
*Material between asterisks is new or revised*
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-2020-D-0957.