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FDA Casts a Light on Radiation Emitting Devices

On August 12, 2013, the Director of the U.S. Food and Drug Administration’s (FDA) Division of Import Operations, Capt. Domenic Veneziano, requested that U.S. Customs and Border Protection (CBP) provide notification to FDA of all importations of visible and non-visible laser products (Laser Pointers, Laser Gunsights, Laser Levels, Laser Light Shows, Laser Pointer Key Chains, Veterinary Laser Products, Laser Illuminators & Similar Products), including those entered as “Section 321” or informal entries.

FDA regulates Radiation-Emitting Electronic Devices intended for use in the United States by humans or other animals. FDA defines Radiation-Emitting Electronic Devices as “any product that contains an electronic circuit and generates any kind of radiation.” Radiation-Emitting Electronic Devices are manufactured or assembled products (or component, part, or accessory of such product) which, when in operation, contain or act as part of an electronic circuit and emits (or in the absence of effective shielding or other controls, would emit) electronic product radiation. “Electronic product radiation” is defined by FDA as any ionizing or non-ionizing electromagnetic or particulate radiation, or any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product. Accordingly, FDA regulates Visible and Non-Visible Laser Products as Radiation-Emitting Electronic Devices. FDA has the authority to determine the admissibility for Laser Products imported into the United States.

Importers of radiation emitting-electronic products that are subject to a federal performance standard under 21 CFR 1040.10 must submit information on each product shipment to CBP and FDA. CBP requires importers to affirm that products they are importing comply or do not comply with federal performance standards. FDA regulations limit the energy output of hand­held laser pointers to less than 5 milliwatts (mW), and be labeled as Class lila. These high powered laser pointers can come in several colors such as red, green and/or blue.

Some foreign distributors of laser products are marketing and selling these electronic products to U.S. consumers directly. A number of these laser pointer shipments are entering the United States via courier hubs and international mail facilities. Such shipments are usually informal entries, in small, personal use-sized shipments, and may be misdeclared or labeled as “party lights,” “toys,” “flashlights.”

Products that do not meet all applicable FDA requirements will be detained by FDA, and unless the requirements are met, they will be refused admission into the US. Importations of this type do not meet FDA’s criteria for enforcement discretion for personal importation.

FDA has asked CBP to take action to prevent their delivery and distribution by monitoring small packages which could contain those illegal hand-held laser pointers. Additionally, FDA has issued Import Alert 95-04 (Dated August 21, 2013) for “Detention without Physical Examination of Laser Pointers, Laser Gunsights, Laser Levels, Laser Light Shows, Laser Pointer Key Chains, & Similar Products That Fail to Comply with Applicable Performance Standards and Reporting Requirements.” FDA Import Alert 95-04 specifically lists 137 companies subject to Detention without Physical Examination (DWPE). Although the list contains companies from seven different countries, Chinese exporters lead the list of Laser Product exporters on DWPE:

Canada- 3
China- 88
Germany- 1
Hong Kong- 11
Japan- 2
Taiwan- 31
United Kingdom- 1

In order to stop the DWPE process, a formal petition must be submitted to FDA. This petition must clearly detail to FDA the corrective actions taken to ensure that the problems that caused the items to be placed on Import Alert have been eliminated and will not reoccur.

In a recent conference call with FDA, an FDA official indicated that well-organized petitions, like those prepared by some consultants, move more quickly through FDA’s review process. Registrar Corp‘s team of multilingual specialists has experience in drafting successful petitions to FDA. Registrar Corp assists companies through this critical process and provides them with the best possible chance of being quickly and successfully freed from the financial and logistical burdens of DWPE.

Additionally, every manufacturer of electronic products, (whether on DWPE or not) must designate a U.S. Agent for service of processes. Some manufacturers, assemblers, or importers of electronic products may also be required to provide additional Product Reports to FDA.

Registrar Corp can serve as U.S. Agent for service of process and assist companies with submission of Product Reports, if required. Contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177 for regulatory assistance with electronic products or any other FDA-regulated products.