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Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30)

FinalCenter for Devices and Radiological Health,Office of Product Evaluation and Quality,Office of In Vitro Diagnostics and Radiological Health11/05/2005

Description

U.S. Department Of Health And Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health

Scope & Applicability

Product Classes

3
R Type lamps

Non-self extinguishing lamps requiring warning packaging

T Type lamps

Self-extinguishing lamps addressed by the performance standard

High-Intensity Mercury Vapor Discharge Lamps

Subject of the performance standard and guidance

Stakeholders

3
FDA import staff

Personnel responsible for reviewing and detaining importations

importer

Person responsible for establishing FSVP; Person in the United States who owns or has purchased the food at time of entry; entity responsible for FSVP compliance; Entity responsible for FSVP compliance; Entity responsible for conducting hazard analysis; Subject of FSVP requirements for food for humans and animals.; The entity responsible for FSVP compliance and supplier approval.; entity responsible for foreign supplier verification; entity responsible for developing FSVP; entity responsible for

manufacturer

Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.

Identified Hazards

Hazards

1
ultraviolet radiation

Radiation that escapes when the outer envelope of an HID lamp is broken

View on FDA.govDownload PDF

Related CFR Sections (1)

See Also (1)

Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30) | Guideline Explorer | BioRegHub