Description
The Performance Standard for Laser Products (21 CFR 1040.10 and 1040.11) became effective August 2, 1976. Lasers and products containing lasers manufactured on or after that date must conform to the applicable provisions of the standard. In addition, manufacturers will be required to certify that their products comply with the regulations and to furnish reports to the Bureau of Radiological Health which clearly substantiate the product compliance.
Scope & Applicability
Product Classes
9Specific electronic product requiring user information under 21 CFR 1040.10(h)
Any manufactured product or assemblage of components which constitutes, incorporates, or is intended to incorporate a laser or laser system
Laser products intended for in vivo irradiation
Highest power laser products requiring stringent safety features and calibration
Higher power laser products requiring remote control connectors and emission indicators
Laser products requiring specific emission indicators and beam attenuators
Laser products with the lowest accessible emission limits
Laser product classification
Laser products intended for medical use
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
5Light generation parameter for device description.; Technical parameter in nanometers
compliance is required for the useful life of the product
Components of uncertainty in calibration; Total uncertainty that must be accounted for when setting rejection criteria
Spatial characteristics and emission durations of laser products
Quantitative estimates of errors associated with measurements.
Identified Hazards
Hazards
3Radiation emitted by products that must be protected against
Optical, electromagnetic, or x radiation from laser operation
Radiation that can be reached by a human or defined probe; measurements must be made to maximize the emission
Related CFR Sections (6)
- 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 →
- 21CFR1002.10§ 1002.10 Product reports.
Every manufacturer of a product or component requiring a product report as set forth in table 1 of § 1002.1 shall submit a product report to the Food and Drug Administration, Center for Devices and Radiological Health, ATTN: Electronic Product Reports, Document Mail Center, 10903 New Hampshire Ave.,Read full regulation →
- 21CFR1002.12§ 1002.12 Abbreviated reports.
Manufacturers of products requiring abbreviated reports as specified in table 1 of § 1002.1 shall submit, prior to the introduction of such product, a report distinctly marked “Radiation Safety Abbreviated Report” which shall include:Read full regulation →
- 21CFR1010.2§ 1010.2 Certification.
(a) Every manufacturer of an electronic product for which an applicable standard is in effect under this subchapter shall furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards under this subchapter.Read full regulation →
- 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 →
See Also (8)
- Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25) (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)
- Manufacture and Certification of Laser Kits (Laser Notice 13) (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)