Description
The purpose ofthis memorandumis to notify all laser product manufacturers of exemptions granted for laser products intended for U.S. Government use (21 CFR 1010.5). These laser products may not be the same as models that are certified and sold or leased commercially. They are to be used exclusively by (1) the National Oceanic and Atmospheric Administration, U.S. Department of Commerce or by (2) the Department of Energy or by its contractors at DOE designated, government-owned contractor-operated (GOCO) facilities in unique research applications or as components in larger research and development systems. The exemption is from the FDA performance standard for laser products, 21 CFR 1040.10 and 1040.11, and the associated reporting and recordkeeping requirements, 21 CFR Part 1002, except for paragraph 1002.20 relating to accidental radiation occurrences.
Scope & Applicability
Product Classes
1Any manufactured product or assemblage of components which constitutes, incorporates, or is intended to incorporate a laser or laser system
Stakeholders
1Entities responsible for manufacturing and labeling the laser products
Identified Hazards
Hazards
1Safety concern that remains subject to reporting even under exemption
Related CFR Sections (4)
- 21CFR1002.20§ 1002.20 Reporting of accidental radiation occurrences.
(a) Manufacturers of electronic products shall, where reasonable grounds for suspecting that such an incident has occurred, report to the Director, Center for Devices and Radiological Health, all accidental radiation occurrences reported to or otherwise known to the manufacturer and arising from theRead 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 →
- 21CFR1010.5§ 1010.5 Exemptions for products intended for United States Government use.
(a) Criteria for exemption. Upon application by a manufacturer (including assembler) or by a U.S. department or agency, the Director, Center for Devices and Radiological Health, Food and Drug Administration, may grant an exemption from any performance standard under subchapter J of this chapter for Read full regulation →
See Also (8)
- Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21-CFR 1020.40 (Status: Final)
- Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9) (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) (Status: Final)
- Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54): Guidance for Industry and FDA Staff (Status: Final)
- Compliance Guide for Cabinet X-Ray Systems (Status: Final)
- Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55) (Status: Final)
- Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment (Status: Final)