Description
The purpose ofthis memorandumis to notify all laser product manufacturers of an exemption granted for all laser products which are manufactured after August 2, 1976, and used exclusively by DOD agencies, and which are designed for actual combat or combat training operations or are classified in the interest of national defense (Reference FDA Docket No. 76P-0335). The exemption does not apply to laser products intended primarily for use in indoor classroom training and demonstration, industrial operations, and scientific investigations; and medical laser products. The exemption is from the FDA performance standard for laser products in 21 CFR Part 1040.10 and 1040.11 and the associated reporting and record keeping requirements of 21 CPR Part 1002, except for paragraph 1002.20 relating to accidental radiation occurrences.
Scope & Applicability
Product Classes
3must comply with 1040.10 and additional measurement requirements
Specific category of laser products granted exemption
Any manufactured product or assemblage of components which constitutes, incorporates, or is intended to incorporate a laser or laser system
Stakeholders
1Entities notified of the regulatory exemption
Identified Hazards
Hazards
1Radiation emitted by products that must be protected against
Related CFR Sections (3)
- 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 →
See Also (8)
- Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21-CFR 1020.40 (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) (Status: Final)
- Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25) (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)