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S. commerce or if they must be held under bond until exported destroyed or reconditioned. Until the shipment is released it may be subject to redelivery for FDA examination. PAPER OR ELECTRONIC SUBMISSION Paper entries may be made by submitting the signed original FDA 2877 along with U.S. Customs forms to the local FDA district office if electronic products are given a MAY PROCEED a signed copy of CF 3461 will be returned or if not given a MAY PROCEED a FDA Notice of Action will be issued. For e ...

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What is a form 2877?

Form FDA 2877 (Declaration For Electronic Products Subject to Radiation Performance Standards), or the equivalent electronic filing, must be submitted to the FDA district office before the shipment arrives.

How do I find my FDA accession number?

Accession numbers are unique identifiers for reports in our database and are provided in the CDRH acknowledgement of receipt letters.

What is a form 2877?

Does FDA regulate LED lights?

LED products emit visible optical radiation, which qualifies them to be radiation-emitting electronic products and gives FDA regulatory authority.

Does the FDA regulate radiation-emitting products?

Radiation-emitting electronic products are regulated by FDA and are required to comply with the general requirements found in 21 CFR 1000-1005.

2877 form

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Does the FDA regulate electronic products?

FDA is responsible for regulating radiation-emitting electronic products. The agency's goal is to protect the public from hazardous and unnecessary exposure to radiation from electronic products. (ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation.

How does the FDA regulate radiation?

FDA regulates radiation emitting electronic products. The purpose is to prevent unnecessary exposure to radiation due to the use of these products. There are specific requirements that apply to all radiation emitting electronic products in order to comply with the provisions of the Food, Drug and Cosmetic Act.

What is radiation emitting electronic products?

FDA defines a radiation-emitting electronic product as any electrically-powered product that can emit any form of radiation on the electromagnetic spectrum.

Does FDA regulate LED lights?

LED products emit visible optical radiation, which qualifies them to be radiation-emitting electronic products and gives FDA regulatory authority.

Does the FDA regulate radiological devices?

The United States (U.S.) Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is responsible for regulating radiation-emitting electronic products.

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