Description
Thisguidancedescribes the Food and Drug Administration’s (FDA) approach regarding manufacturers’ compliance with FDA’s performance standards for laser products. FDA recognizes that while there are many similarities between International Electrotechnical Commission (IEC) standards 60825-1: Safety of laser products - Part 1: Equipment classification, and requirements, Edition 3.0 and 60601-2-22: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment, Edition. 3.1 and FDA’s laser performance standards, there are clauses of these IEC standards that differ significantly from FDA’s performance standards for laser products. For the manufactures that conform to the clauses of IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 that FDA identifies as comparable with 21 CFR 1040.10 and 1040.11, FDA does not intend to enforce the applicable requirements in 21 CFR 1040.10 and 1040.11.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
5High power laser radiation classification
Laser radiation classification requiring safety interlocks
Laser products intended for medical use
FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices
Any manufactured product or assemblage of components which constitutes, incorporates, or is intended to incorporate a laser or laser system
Regulatory Context
Regulatory Activities
2Application for deviation from performance standards
FDA or State approval to provide mammography services; The regulatory status required for a facility to perform mammography.
Attributes
2Limit used for laser classification
Requirement under 21 CFR 1040.10(d)
Technical Details
Substances
1Controlled stimulated radiation emitted through aperture
Testing Methods
1Testing to confirm proper laser product classification
Identified Hazards
Hazards
1Collateral radiation hazard from high voltage laser products
Standards & References
External Standards
2Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment; Safety of medical laser equipment
Safety of laser products - Part 1: Equipment classification, and requirements; Safety of laser products - Part 1: Equipment classification and requirements
Related CFR Sections (7)
- 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 →
- 21CFR1010.4§ 1010.4 Variances.
(a) Criteria for variances.Read full regulation →
- 21CFR1002.1§ 1002.1 Applicability.
The provisions of this part are applicable as follows: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 →
- 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 →
- 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)
- Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25) (Status: Final)
- Compliance Guide for Cabinet X-Ray Systems (Status: Final)
- Surveying, Leveling, and Alignment Laser Products: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice 43) (Status: Final)
- Laser Light Shows Subject to Laser Product Performance Standard (Laser Notice 22) (Status: Final)
- Compliance Guide for Laser Products (FDA 86-8260) (Status: Final)
- Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; (Laser Notice 51) (Status: Final)
- Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55) (Status: Final)