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High-Intensity Mercury Vapor Discharge Lamps: Scope of Performance Standard and Requirements for General Purpose Lighting vs. Specialized Applications

This guidance clarifies that the performance standard (21 CFR 1040.30) for High-Intensity Mercury Vapor Discharge Lamps (HID) applies only to lamps used for general purpose lighting (e.g., in gymnasia, auditoriums, and stores), not to specialized applications like projection televisions.

  1. Determine if your HID lamp is intended for general purpose lighting or specialized application
  2. For general purpose lighting HID lamps:
    • Ensure compliance with self-extinguishing requirements for T Type lamps
    • Include appropriate warnings on R Type lamp packaging
    • Submit FD Form 2877 for import clearance
  3. For specialized application HID lamps:
    • Document intended use clearly in product documentation
    • Reference this guidance when responding to import officers
    • No FD Form 2877 required for import
  4. Maintain documentation of intended use and application to support regulatory classification

Key Considerations

Labelling

  • Non-self extinguishing (R Type) lamps must have packaging warnings indicating they should not be used in locations where people congregate for more than a few minutes

Safety

  • Lamps must meet performance criteria for self-extinguishing (T Type) lamps when used for general purpose lighting
  • The glass outer envelope must block transmission of short wavelength ultraviolet radiation from the discharge tube

Other considerations

  • The standard applies only to HID lamps manufactured or assembled after March 7, 1980
  • Specialized applications (e.g., projection TV lamps) installed inside equipment and not subject to external impact are outside the scope
  • 21 CFR 1040.30: Performance Standard for High-Intensity Mercury Vapor Discharge Lamps

Original guidance

  • High-Intensity Mercury Vapor Discharge Lamps: Scope of Performance Standard and Requirements for General Purpose Lighting vs. Specialized Applications
  • HTML / PDF
  • Issue date: 2005-11-05
  • Last changed date: 2020-03-24
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products
  • ReguVirta summary file ID: 0ff6e9adb39cf8c1f435a46d466a2a41
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