enLIGHTenment – The Lighting Industry Trade Publication

Why Is the FDA Concerned About LEDs?

Believe it or not, LEDs emit radiation – as do high-intensity mercury vapor discharge lamps – and, as such, fall under the enforcement of the Food & Drug Administration.

According to ALA Engineering Committee member Carl Bloomfield, Director/Lighting for the international inspection, product testing and certification company Intertek, the FDA clarified its enforcement of Light-Emitting Diode (LED) reporting via the U.S. Customs and Border Protection portal in June

He noted the FDA has regulatory authority over radiation-emitting electronic products, which are defined in 21 CFR 1000.3 as any electrically powered product that can emit any form of radiation on the electromagnetic spectrum (LED products emit visible optical radiation). 

THE PERFORMANCE STANDARDS

The performance standards for lighting products are found in 21 CFR Subchapter J Part 1040 of FDA documentation. Part 1040 is titled “Performance Standards for Light-Emitting Products,” but there are no specific requirements for LED.

1040.10 – Applies to laser products

1040.11 – Applies to specific purpose laser products

1040.20 – Applies to sunlamp products and ultraviolet lamps intended for use in sunlamp products

1040.30 – Applies to high-intensity mercury vapor discharge lamps

According to information provided by Bloomfield, typical factors within the performance standards are: source wavelength, radiant energy, irradiance, and radiance.

As per the FDA’s reporting guidelines, manufacturers are required to maintain records and submit reports to the Center for Devices and Radiological Health (CDRH) for their electronic products that emit radiation.

Reports must be submitted before a manufacturer can sell its product. If the product is imported, it is recommended to submit the corresponding report at least one month before those products arrive at the border/U.S. Customs. The CDRH needs at least one month to acknowledge receipt of the report and provide an accession number.

Bloomfield shared with the Engineering Committee that “currently the regulation appears only applicable to lamps (bulbs), however discussions are on-going to determine if LED luminaires will be within that scope.”

Need More Definition?: Radiofrequency (RF) electromagnetic radiation (EMR) is the transfer of energy by radio waves. Any product that contains an electronic circuit and generates any kind of radiation is an electronic product that emits radiation. X-radiation (X rays), microwaves, radio waves, laser, visible light, sound, ultrasound, and UV light are a few examples.

 





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