Description
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.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1Specific class of lasers where the standard warning may be inappropriate
Stakeholders
2Manufacturer of the final system like music systems or computers
Entity 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.
Regulatory Context
Document Types
1Tag or label permanently affixed to the product for tracing
Standards & References
Specifications
1Safety limit for laser radiation
Related CFR Sections (3)
- 21CFR1010.3§ 1010.3 Identification.
(a) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall set forth the information specified in paragraphs (a)(1) and (2) of this section. This information shall be provided in the form of a tag or label permanently affixed or inscribed on such prRead 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 →
- 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 →
See Also (8)
- Addition of URLs to Electronic Product Labeling: Guidance for Industry and FDA Staff (Status: Final)
- Laser Energy Source (Laser Notice 2) (Status: Final)
- Quality Control Practices for Compliance with the Federal Laser Performance Standard (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)
- 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)
- User Instruction Hazard Warnings (Laser Notice 35) (Status: Final)