Import Alert 95-02
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 95-02
Published Date: 10/12/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Infrared Vision Laser Illuminators and Scopes From Russia That Incorporate A Laser Illuminator"
Reason for Alert:
CDRH/Division of Compliance Operations has identified infrared night vision laser illuminators and scopes from Russian manufacturers as violating Sections 536, 537 and 538 of the FFDCA and 21 CFR 1002.10 and as being potentially hazardous laser products. The products have no certification that complies with the appropriate performance standard for laser products and no initial report from Russian manufacturers have been received by CDRH.
Guidance:
Districts may detain without physical examination infrared night vision laser illuminators and scopes from Russia lacking certificates, initial reports, or user instructions. Products should be refused entry unless the importer corrects the product deficiencies or is able to show that the product is properly certified and meets the performance Standards (21 CFR 1010.2 and 1010.3).
It may be necessary to field test some products to ensure the importer has effected the correction of the detained product. Contact CDRH at (301) 427-1172 for additional guidance. Also contact CDRH for information regarding submission of required reports and guidelines for detention.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.
It may be necessary to field test some products to ensure the importer has effected the correction of the detained product. Contact CDRH at (301) 427-1172 for additional guidance. Also contact CDRH for information regarding submission of required reports and guidelines for detention.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.
Product Description:
Infrared Laser Illuminators (a.k.a. night vision illuminators and scopes which incorporate a laser illuminator).
Scopes without the laser illuminator are not subject to DWPE.
Scopes without the laser illuminator are not subject to DWPE.
Charge:
If device is noncompliant with applicable standard and/or lacks certification, charge:
"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 to be an electronic product which fails to comply with an applicable standard as prescribed under this subchapter or to which is not affixed a certification in the form of a label or tag in conformity with Section 534(h)."
OASIS charge code - NO TAG
If no reporting is done, charge:
"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 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
"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 to be an electronic product which fails to comply with an applicable standard as prescribed under this subchapter or to which is not affixed a certification in the form of a label or tag in conformity with Section 534(h)."
OASIS charge code - NO TAG
If no reporting is done, charge:
"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 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
Countries
RUSSIA
(95 L - - 22) Laser Product for Non-Medical Use
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