Fd2877 2025

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PURPOSE: The Form FDA 2877 must be completed for electronic products subject to Radiation Control Standards (21 CFR 1010 and 1020-1050) prior to entry into the United States.
(1) At least 10 foot candles (108 lux) at a distance of 30 inches (75 cm) above the floor, in walk-in refrigeration units and dry FOOD storage areas and in other areas and rooms during periods of cleaning; (2) At least 20 foot candles (215 lux): (a) At a surface where FOOD is provided for CONSUMER self-service such as
Although there is no performance standard for LEDs, they do require reporting to FDA, the same as any other radiation-emitting product. Reporting is required whether an importer is bringing in LED bulbs only or products that contain LED bulbs.
Accession numbers are unique identifiers for reports in our database and are provided in the CDRH acknowledgement of receipt letters. An accession number facilitates communication about specific reports because all parties can use the accession number to identify the document being discussed.
Radiation-emitting electronic products are regulated by FDA and are required to comply with the general requirements found in 21 CFR 1000-1005.

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LED lighting manufactured or imported for sale in the United States must comply with various regulations and standards. On top of that, there are also voluntary standards that in practice are required.

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