us-fda-guidance-450dc4a43518c94762f40bf83f002e10•Identification Labels for Certain Class I Laser Products (Laser Notice 48)
Identification Labels for Certain Class I Laser Products (Laser Notice 48)
us-fda-guidance-450dc4a43518c94762f40bf83f002e10Identification Labels for Certain Class I Laser Products (Laser Notice 48)Guidance
Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.
- Docket Number:
- FDA-2020-D-0957
- Issued by:
- Guidance Issuing OfficeCenter for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of In Vitro Diagnostics and Radiological Health
The regulations for electronic products require each electronic product for which a standard has been promulgated to be identified with the name and address of the manufacturer (21 CFR 1010.3}. This identification is to be on a tag or label permanently affixed to the product. Identification of the product is required so the product may be traced for recall in the event there is a defect in the product or the product is found to be noncompliant. This requirement is applicable to all laser products certified as complying with the Federal performance standard for laser products, 21 CFR 1040.10 and 1040.11.
Submit Comments
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:
Dockets Management
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.
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