Description
To: All Manufacturers and Potential Manufacturers of Laser ProductsSubject:Reproduction of Hazard Warnings in User Instructions
Scope & Applicability
Product Classes
1Specific electronic product requiring user information under 21 CFR 1040.10(h)
Stakeholders
1Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Identified Hazards
Hazards
1Required safety information to be reproduced in user instructions.
Related CFR Sections (2)
- 21CFR1040.10§ 1040.10 Laser products.
(a) Applicability. The provisions of this section and § 1040.11 , as amended, are applicable as specified to all laser products manufactured or assembled after August 1, 1976, except when:Read full regulation →
- 21CFR1040.11§ 1040.11 Specific purpose laser products.
(a) Medical laser products. Each medical laser product shall comply with all of the applicable requirements of § 1040.10 for laser products of its class. In addition, the manufacturer shall:Read full regulation →
See Also (8)
- Quality Control Practices for Compliance with the Federal Laser Performance Standard (Status: Final)
- Laser Energy Source (Laser Notice 2) (Status: Final)
- Viewing Optics - Sighting Telescope (Laser Notice 8) (Status: Final)
- Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9) (Status: Final)
- Identification Labels for Certain Class I Laser Products (Laser Notice 48) (Status: Final)
- User Instruction for Medical Products (Laser Notice 44) (Status: Final)
- Class II and IIIA Laser Light Show Projectors and Shows (Laser Notice 40) (Status: Final)
- Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25) (Status: Final)