Post

In-House Manufactured Laser Products: Applicability of Federal Performance Standards

This guidance clarifies when in-house manufactured laser products used in manufacturing processes are subject to the Federal Performance Standard for Laser Products and other regulations.

  1. Assess whether your in-house laser manufacturing activities constitute “being engaged in the business” based on:
    • Frequency of manufacture (one-time vs. continuous)
    • Who uses the laser products
    • Commercial nature of the operation
  2. If determined to be “engaged in the business”:
    • Implement compliance with Federal Performance Standard
    • Establish certification procedures
    • Maintain required documentation
  3. If determined to be one-time construction:
    • Document the one-time nature of the build
    • Ensure usage is restricted to the place of construction
  4. Establish clear procedures for tracking any changes in manufacturing patterns that could affect regulatory status

Key Considerations

Safety

  • Laser products made on a continuing basis and used by employees not directly involved in their manufacture must comply with the Federal Performance Standard
  • One-time constructed laser products used only at the place of construction are exempt from the standard

Other considerations

  • 21 CFR 1040: Performance Standards for Light-Emitting Products

Original guidance

  • In-House Manufactured Laser Products: Applicability of Federal Performance Standards
  • HTML / PDF
  • Issue date: 1976-11-23
  • Last changed date: 2021-01-26
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Laser Notice
  • ReguVirta summary file ID: 432c35930ea66afa9301671b8c26401f
This post is licensed under CC BY 4.0 by the author.