Import Alert 95-04

"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."

NOTE:
The revision of this Import Alert dated 7/30/2010 updates the background information and adds information regarding removal from DWPE. Changes are noted and bracketed by three asterisks (***).

This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or product(s) at issue. It does not create or confer any rights for, or on any person, and does not operate to bind the FDA or the public.


*** This Import Alert was originally issued in December 1997 after investigation by FDA's San Francisco District (SAN-DO) revealed numerous laser products from numerous foreign suppliers were subject to refusal as indicated by sections 536 of the FFDCA, for violations of section 534, 21 CFR 1002.10, 1010.2, 1010.3, 1040.10(g) and/or 1040.10(h).

FDA continues to encounter violations with foreign manufactured laser products. ***

*** Districts may detain without physical examination (DWPE) all shipments of the same product as was originally found violative such as laser pointers, laser gunsights, laser levels, laser pointer key chains, laser light show projectors, and similar products (covered laser products) from the manufacturers/shippers listed on the attachment to this alert.

In addition, covered laser products are subject to detention if, among other reasons, an examination shows they do not appear to comply with the appropriate standard as follows:

(1) The laser product does not have a permanently attached warning logotype label;
(2) The laser product output exceeds 5 milliwatts;
(3) The laser product fails to contain certification or identification information either on the product or in the instructions for use;
(4) The laser product fails to contain instructions for safe use;
(5) The product class or output information on the laser product's warning logotype label is different from that in the instructions for use; and/or
(6) A product report for the laser product has not been submitted. ***

For a covered laser product where:

(1) there is not an emission indicator;
(2) there is not a separate beam attenuator; or
(3) the certification and identification information is in the instructions for use rather than on the product itself.

*** Refer to the guidance documents Laser Notices 43 and 53 (available at http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/IndustryGuidance) for information about FDA's compliance policies in these situations. ***

*** In order to remove a firm from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. For example, when appropriate, the request should include information for FDA to adequately assess whether the manufacturer's quality control and testing program is in compliance with the Electronic Product Radiation Control Act (Federal Food, Drug and Cosmetic Act, Chapter V, Subchapter C) and 21 CFR 1010.2 and their laser products comply with the Federal Performance Standard for Laser Products (21 CFR 1040.10 and 1040.11). In addition, under 21 CFR 1002.10(k), the importer must provide other information CDRH may reasonably require to determine whether the importer is in compliance with the Electronic Product Radiation Control Act and applicable standards.

If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:

Food and Drug Administration
12420 Parklawn Drive
ELEM 3109
Rockville, MD 20857

Or via email: Importalerts2@fda.hhs.gov

All requests for removal from detention without physical examination will be referred by DIOP to CDRH'S Electronic Products Branch for evaluation.

For questions concerning specific information for the removal from this Import Alert, please contact Robert Doyle, Chief of Electronic Products Branch, Division of Mammography, Quality, and Radiation Programs, CDRH, 10903 New Hampshire Avenue, WO66-4664, Silver Spring, Maryland 20993-0002. (Robertj.Doyle@fda.hhs.gov, 301-796-5863). ***

Laser Pointers, Laser Gunsights, Laser Pens, Laser Light Show Projectors, Laser Special Effects, Laser Levels, Toy Guns with Lasers, Laser Pointer Key Chains, and similar products.

*** "The article is subject to refusal of admission pursuant to Section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears that the article fails to comply with applicable standards prescribed under section 534 [Non standard, Section 536(a)]"
OASIS charge code: NON STD

and/or

"The article is subject to refusal of admission pursuant to Section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears that the article does not have affixed to it a certification in the form of a label or tag in conformity with section 534(h) [Not certified, Section 536(a)]"
OASIS charge code: NO TAG

and/or

"The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b)."
OASIS charge code: NO REGISTR ***


OASIS charge code - NO TAG
OASIS charge code - NOT STD
OASIS charge code - NO REGISTR