- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Medical Products and Tobacco, Center for Devices and Radiological HealthOffice of Global Regulatory Operations and Policy, Office of Regulatory Affairs
On February 11, 1980, *the Bureau of Radiological Health (BRH), now the Center for Devices and Radiological Health (CDRH)* wrote to all manufacturers and potential manufacturers of these lamps that the following warning statement is required in advertisements for high-intensity mercury vapor discharge lamps which are not self-extinguishing: "WARNING: This lamp can cause serious skin burns and eye inflammation from shortwave ultraviolet radiation if outer envelope of the lamp is broken or punctured. Do not use where people will remain for more than a few minutes unless adequate shielding or other safety precautions are used. Lamps that will automatically extinguish when the outer envelope is broken or punctured are commercially available."
The word "advertisement" is defined in the standard (21 CFR 1040.30(b)(2)) to mean "any catalog, specification sheet, price list, brochure and literature, including videotape and film, pertaining to high-intensity mercury vapor discharge lamps." Specifically, lamp manufacturers wanted to know whether all price schedules (or price lists), videotapes and films for such lamps must carry the required warning statement. Some manufacturers contended that, since some price schedules are simply intended to update the prices and are issued rather frequently (compared with the issuance of the general catalog), and purchasers must refer to the general catalog for performance information on the lamp, there is no need to provide the required warning in the separate price schedules. One manufacturer also argued that any videotape, film or other advertising literature for such lamps intended for the education of the general public should not carry the required warning statement either.
The purpose of including the warning statement in advertisements is to make potential purchasers aware of the hazards of non-self-extinguishing high-intensity mercury vapor discharge lamps. Therefore, separate warnings on price schedules are not required if they are intended for use only by distributors and dealers, or they are clearly an integral part of the general catalog of such lamps since the general catalog will have the warning. Similarly such warnings are not required in a videotape, film or other literature which does not provide information for selection of high-intensity mercury vapor discharge lamps. Price schedules which provide information for the selection of lamps and are intended to be furnished to purchasers must carry the required warning if they are distributed as separate documents from the general catalog for such lamps. Similarly, a videotape, film or other advertising literature must display the required warning statement if it provides purchasing information from which the potential purchasers can directly select the lamp.
*September 7, 1979 Federal Register (44 FR 52191)*
*Material between asterisks is new or revised*
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