March 21, 2025

Introduction

FDA Laser Notice No. 56, issued by the U.S. Food and Drug Administration (FDA), marks a critical shift in regulatory compliance for laser products, including medical devices. This notice aligns FDA requirements with International Electrotechnical Commission (IEC) standards, specifically IEC 60825-1 and IEC 60601-2-22, promoting global standardization. With the phase-out of Laser Notice No. 50 by December 31, 2024, manufacturers must transition to the new requirements to maintain compliance and global market access.

Purpose and Scope

The primary goal of Laser Notice No. 56 is to reduce regulatory complexity by enabling manufacturers to comply with internationally recognized standards, rather than separate FDA-specific requirements. This notice applies to all laser products, including those used in medical, surgical, cosmetic, therapeutic, and diagnostic applications.

Key Requirements

  1. Compliance with IEC Standards
    • Medical laser devices must meet safety requirements outlined in IEC 60825-1 (Safety of Laser Products) and IEC 60601-2-22 (Basic Safety and Essential Performance of Laser Equipment).
  2. Product Classification
    • The FDA now recognizes IEC laser classifications, from Class 1 (low-risk) to Class 4 (high-risk), based on potential harm to humans.
  3. Labeling and Hazard Communication
    • Manufacturers must follow IEC standards for warning labels, hazard communication, and user instructions to ensure safe handling and operation.
  4. Testing and Documentation
    • Comprehensive testing and risk assessment documentation must be provided to demonstrate compliance with IEC standards.
  5. Quality Management System (QMS)
    • Adopting ISO 13485 (Medical Devices—Quality Management Systems) ensures consistent manufacturing and product safety.

Benefits of Compliance

Global Market Access – Aligning with IEC standards facilitates international market entry and eliminates redundant testing.

 Enhanced Safety and Performance – Standardized protocols improve patient safety and device functionality.

 Regulatory Streamlining – Reduces regulatory burdens by eliminating duplicative FDA-specific testing.

Transition from Laser Notice No. 50 to No. 56

Laser Notice No. 56 supersedes Laser Notice No. 50 and incorporates the latest IEC standards (IEC 60825-1 Edition 3.0 and IEC 60601-2-22 Edition 3.1). Instead of following 21 CFR 1040.10 and 1040.11, manufacturers can now adhere to certain IEC clauses, eliminating duplicate testing and reducing compliance costs.

Steps for Manufacturers

  1. Conduct a laser hazard assessment.
  2. Classify the laser product per IEC 60825-1.
  3. Implement safety controls and labeling as required.
  4. Maintain comprehensive documentation and testing records.
  5. Submit the necessary documentation to the FDA for approval.

Challenges and Solutions

  • Interpreting IEC Standards Accurately – Partner with experienced testing and certification experts familiar with FDA and IEC requirements.
  • Meeting Documentation Expectations – Maintain detailed records of compliance efforts, including test results, risk assessments, and labelling details.
  •  Ensuring Biocompatibility and Usability Engineering – Verify that device materials are safe for patients and that medical professionals can operate the equipment effectively.

Conclusion

FDA Laser Notice No. 56 represents a significant step toward global harmonization of laser safety standards. By transitioning to IEC standards, manufacturers can simplify regulatory compliance, reduce testing redundancies, and improve patient safety. With Laser Notice No. 50 expiring by December 31, 2024, early adoption of the new standards will help manufacturers reduce costs, accelerate time-to-market, and maintain compliance with the highest safety and performance benchmarks. By embracing these regulatory changes, companies can position themselves as leaders in laser technology, ensuring seamless compliance and innovation in the medical device industry.