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Beam Attenuator and Emission Indicator Requirements for Class II and IIIa Visible Laser Systems

This guidance addresses the requirements for beam attenuators and emission indicators in Class II and IIIa laser systems, specifically focusing on visible laser systems. It provides policy clarification regarding the omission of these features under specific conditions.

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By ReguVirta
3 min read

What You Need to Know? 👇

What are the FDA requirements for beam attenuators in Class II and IIIa laser systems?

The FDA allows omission of beam attenuators for Class II and IIIa visible laser systems that incorporate suitable emission control means like switches, recognizing they provide little safety improvement for systems with short recovery times.

Do Class II and IIIa laser products need emission indicators under FDA regulations?

Class II and IIIa visible laser systems with normally-off, momentary-on switches providing clear tactile indication can omit visible or audible emission indicators, as the physical pressure requirement serves as adequate user notification.

What is the FDA’s current policy on laser safety requirements for visible laser systems?

FDA policy permits omission of beam attenuators and emission indicators for Class II/IIIa visible laser systems with appropriate controls, reducing regulatory burden while maintaining safety through alternative means like tactile feedback switches.

How can manufacturers get approval for alternative laser safety measures?

Manufacturers can apply to the FDA Director for approval of alternate safety means under 21 CFR 1040.10, or request variances under 21 CFR 1010.4 for emission indicator alternatives in qualifying laser products.

What types of laser products qualify for relaxed beam attenuator requirements?

Class II and IIIa visible laser systems with short beam recovery times, readily controllable by operators, and incorporating specific emission control switches qualify for beam attenuator exemptions under FDA policy.

Are there planned changes to FDA laser product performance standards?

Yes, the FDA intends to propose amendments eliminating beam attenuator and emission indicator requirements for visible laser systems currently classified as Class II or IIIa, streamlining regulations for these lower-risk products.

What You Need to Do 👇

  1. Review existing Class II and IIIa visible laser systems to identify opportunities for design simplification
  2. Evaluate current emission control mechanisms to ensure they meet the requirements for omitting beam attenuators
  3. Assess momentary on switches to confirm they provide clear tactile feedback
  4. Document design decisions and justifications for omitting beam attenuators or emission indicators
  5. Maintain compliance records with relevant CFR requirements
  6. Monitor for future amendments to the standard as indicated in the guidance
  7. Consider submitting comments to the Non-Medical Radiological Devices Branch if there are concerns or suggestions regarding the policy

Key Considerations

Human Factors

  • Clear, tactile indication of emission must be provided when using a normally off, momentary on switch

Safety

  • Beam attenuator can be omitted if the laser system incorporates a specific, suitable means of emission control (e.g., switch)
  • Emission indicator (visible or audible) can be omitted if the laser system uses a normally off, momentary on switch
  • The momentary on switch must only operate while physical pressure is applied

Other considerations

  • Applies only to Class II and IIIa visible laser systems
  • Compliance with 21 CFR 1040.10(f)(6)(ii) for alternative means of radiation protection
  • Compliance with 21 CFR 1010.4 for variances related to emission indicators

Relevant Guidances 🔗

Related references and norms 📂

  • 21 CFR 1040.10: Performance Standards for Light-Emitting Products
  • 21 CFR 1010.4: Variances
  • 21 CFR 1003.11: Regulatory Requirements for Notification of Defects
  • 21 CFR 1003.21: Notification to Affected Persons
  • 21 CFR 1003.30: Exemption from Notification Requirements

Original guidance

  • Beam Attenuator and Emission Indicator Requirements for Class II and IIIa Visible Laser Systems
  • HTML / PDF
  • Issue date: 1993-06-07
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiological Health
  • ReguVirta ID: af2f219102628e3026eddf72861f8cec
FDA guidance, Final
Medical Devices Radiation-Emitting Products Radiological Health
This post is licensed under CC BY 4.0 by the author.