- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
The warning statement, "Caution - use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure" required by CFR 1040.10 (h) (l) (iv) to be provided in the user information with laser products has been found to be inappropriate or misleading for certain products. Such instances occur when there are no controls available to the user or there are no adjustments or procedures which the user could reasonably perform during conditions of operation or maintenance which could result in hazardous radiation exposure. Some Class I laser products that have evidenced this condition are business machines, and sealed consumer products.
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.