fda lcd monitors for import made in china

2023-01-03 12:32:11

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fda lcd monitors for import made in china

Today, modern computers displays and televisions (TVs) today use liquid crystal display (LCD), Light-emitting diodes (LED), plasma, or other technologies that do not contain cathode ray tubes (CRTs).

A CRT is a specialized vacuum tube that can be used to receive and display images on an electronic screen. In the early 1960s, some TVs with CRTs were found to emit excessive x-radiation, and a federal performance standard was created to protect the public from this hazard. In the years that followed, the electronic technology for TVs and computer monitors with CRTs changed so drastically that the level of risk of x-ray exposure became almost non-existent. Manufacturers of products that still use CRTs must certify that their products comply with the federal performance standard for the life of the product.

Modern TV receivers and computer monitors provide a benefit for entertainment and information display in many settings. TV receivers and computer monitors containing CRTs no longer pose a risk of emitting any x-radiation. Since the creation of the federal performance standard, the FDA has tested hundreds of TV receivers and computer monitors and rarely encountered any that were unsafe. Most modern computer monitors and televisions (TVs) today use liquid crystal display (LCD), Light-emitting diodes (LED), or plasma and do not contain CRTs or emit x-radiation.

Manufacturers of electronic radiation emitting products sold in the United States are responsible for compliance with the Federal Food, Drug and Cosmetic (FD&C) Act, Chapter V, Subchapter C - Electronic Product Radiation Control.

Manufacturers of televisions and video display products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005:

In addition, TV receivers and monitors with CRTs must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1020:

fda lcd monitors for import made in china

(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).

Note: The revision of this Import Alert (IA) dated 04/6/2022 updates the guidance section, agency contacts and charge code language. Changes to the import alert are bracketed by asterisks (***).

Devices listed on the Red List for this alert have not been determined substantially equivalent or lack either a 510(k) or a Pre-Market Approval (PMA) for commercial distribution or, alternately, lack an Investigational Device Exemption (IDE).

A recommendation for addition to detention without physical examination, including analytical worksheets (if the product was analyzed), labeling, package inserts, user manuals, photographic evidence, website information, entry documents, etc., should be forwarded to the Division of Import Operations (DIO). DIO will coordinate a review of all recommendations for addition to detention without physical examination with CDRH Imports and Registration & Listing Team.

In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the owner, consignee and/or another responsible party to the shipment may submit to the FDA a written application (Form FDA 766) requesting authorization to bring a device that has been detained without physical examination per this import alert into compliance by relabeling or other action (reconditioning). Divisions will refer such applications related to this alert to CDRH Imports and Registration & Listing Team, for concurrence.

For questions regarding device classification, please refer to the "FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act" guidance document: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic

In order to remove a firm"s device from the Red List of this Import Alert, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act).

For guidance on removal from detention without physical examination, refer to FDA"s Regulatory Procedures Manual, Chapter 9, "9-8 Detention Without Physical Examination (DWPE)."

If a firm and/or a representative of the firm would like to request removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

DIO will coordinate the evaluation of a request for removal from detention without physical examination with CDRH Imports and Registration & Listing Team.

Questions or issues involving import operations, should be addressed to the Division of Import Operations at 301-796-0356, or email fdaimportsinquiry@fda.hhs.gov

*** For questions concerning these types of devices or other compliance issues, should be addressed to the CDRH Imports and Registration & Listing Team via the CDRH Import Mailbox email address: cdrhimport@fda.hhs.gov

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for

***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k) application does not appear to have been determined substantially equivalent or otherwise filed. [Misbranding, Section502(o)]***

Notes: Class III. Interfall Hydrogel is a dermal filler marketed for; shaping the face; genitals; mammary glands and buttocks; elimination of deep deforming scars; and endoprosthetics of vocal cords in cases of paralytic stenosis of the larynx; as well as other purposes. Firm name could also be listed in records as Minasian Medical Centre and/or www.consultdrminas.com.

Notes: HIV Oral Test (aka 1; 2 and Subtype O Saliva Test). 10/26/1999. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes: HIV 2 Blood Test Kit. (aka HIV Testing Kit) HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201. 11/9/1999

Notes: HIV 1/2 Saliva Test Kit (aka Easy Home Test or easyhivtest). 9/14/2000. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes: HIV 1 & 2 ELISA. 7/10/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes: 7/9/2004 The canadian firm was issued a warning letter from CDRH on 3/25/2004; warning them to discontinue marketing these devices to the United States. There is currently no evidence that these devices are marketed in the US by the manufacturer. Districts should be aware that although he correct product code for this is 89NHN; the product has been mis-coded as 95L-22 (laser products/Laster product for non-medical use).

Notes: 11/9/1999. HIV 1/2 Blood Test Kit. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes: Class III. Teosyal is a dermal filler intended for treating wrinkles; adding contour to facial features; enhancing the lips and eliminating the appearance of aging. The product is marketed on www.medicaoutlet.com.

Notes: 10/26/1999. Discreet HIV Test. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes: Class II; There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market.

Notes: Class II;There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market.

Notes: HIV 1 & 2 Rapid Test Kit. 2/25/2004. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes: The product labeling; for the device; "Device Abuse Test;" appears to be lack adequate directions for use. Device Classification is unknown.

Notes: Class II Device (may be a Class III). The device claims made are varied and the mechanism of technology of the device is and it is unclear how the device produces the intended effects are unclear. CDRH is not aware of any predicate devices that the manufacturer may compare to for 510(k) submission. Therefore; there is no specific product code or regulation that applies to this device since there are no known predicate device(s).

Notes: 2/16/2007 HIV Self Test Kit HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes: Class III. Hyaluronic Acid Gel is a dermal filler marketed for the treatment of wrinkles and for buttocks and breast augmentation. Product is marketed on www.BeautyCosmeticStore.com.

Notes: Shipper for Guanzhou NuhNan Shandong Medicines and Health Products. Positive/Negative Integrated Computer Control Augmented Sequential External Counter-Pulsation Device.

Notes: Class II Device. The Agency is unable to determine if the product is a device subject to a previously cleared 510(K) due to the lack of information in the product materials.

Notes: Class 2;For example; claims include Rehabilitation treatment for the diseases such as headaches; migraine headaches; neck and shoulder acid; stomach pain; fatigue; abnormal blood pressure; constipation; weight loss; detoxification; lack of sleep; insomnia; cold; pressure; dysmennorheal; menopause syndrome; irregular menstruation; infertility; etc.

Notes: Class II;Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k)

Notes: Class II;Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k).

Notes: Class II;Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k)

Notes: HIVSCAN 1 2 Kit (Human Immunodeficiency Virus HIV-1 & HIV02 Test Kit) 10/28/2005. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes: OC"s HIV - 1/2 Antibody HIV1/2 Whole Blood One Step Test 9/19/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes: Electro Physiological Feedback Xrroid (EPFX) Quantum Xrroid (QXCl) QXCl Accessories Scientific Conscionesssness Interface Operations System (SCIO) Virtual Reality Imagery; Ascultacardiogram; CLASP 32 Master Program 1 CD; CLASP 32 Master Program 2 CD; Living Information Forms Energy L.I.F.E System 1/4/2008.

Notes: HIV I and II One Step Tests 7/9/1998. Several FDA districts have encountered shipments of unapproved test kits and labeled for "research use only" or "investigationa use only" and some of the kits were unlabeled. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. Investigation by FDA revealed that the unapprived HIV diagnostic test kits were intended for commercial distribution; and not for "research" or "investigation" uses as invoiced. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201

Notes: Device Classification is unknown. The Double Eyelid Tape appears to exceed the limitations of exemptions for 21CFR 880.5240 as the device is intended for a different intended use (i.e., to permanently reshape the eyelids rather than to cover/protect wounds, to hold together skin edges of a wound, to support an injured part of the body, or to secure objects to the skin).

Notes: HIV 1/2 Whole Blood Test Kit. 11/9/1999. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes: HIV 1/2 HIV 2 Subtype O Serum; Plasma or Whole Blood Test Kit. (aka HIV/AIDS test kit) 1/29/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes: HIV 2 Blood Test Kit 5/25/2000 HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

The labeling for Otostick states that it is an "ear correction device" for which "some adaptation time may be required" and "correct adaptation without any discomfort will be progressively achieved." The labeling also states "corrects excessive prominence of the ears." The intended use appears to cause structure change to the placement of the ears.

Notes: HIV Test Kits. 2/24/2009. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes: Ion Magnum IV Body and Face Medical Device (Trade names Ion Genius; Forever Young Arasys Perfector; Ion research; Ion Medica and Ion Magnum); Class II

fda lcd monitors for import made in china

Products that use laser energy come in many sizes, shapes and forms. What they have in common is a laser which stores energy from a source, such as, an electrical discharge, chemical reaction or powerful optical illumination that releases the energy as light.

Laser stands for Light Amplification by the Stimulated Emission of Radiation. One basic type of laser consists of a sealed tube, containing a pair of mirrors, and a laser medium that is excited by some form of energy to produce visible light, or invisible ultraviolet or infrared radiation.

Laser products improve the quality, precision, accuracy, security and reliability of many forms of products, materials, communications and data handling. In order to realize the benefits of lasers, the risks of laser exposure must be managed.

The FDA recognizes four major hazard classes (I to IV) of lasers, including three subclasses (IIa, IIIa, and IIIb). The higher the class, the more powerful the laser is and the greater the potential to pose serious injury if used improperly. The labeling for Classes II–IV must include a warning symbol that states the class and the output power of the product. Roughly equivalent IEC classes are included for products labeled under the classification system of the International Electrotechnical Commission.

Manufacturers of electronic radiation emitting products sold in the United States are responsible for compliance with the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control.

Manufacturers of laser products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005:

In addition, laser products must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1040:

The document Exemptions from Electronic Product Regulationshas been assembled to simplify the process of finding all the exemptions provided for in the Code of Federal Regulations (CFR) Parts 1000-1050 and those granted by an agency letter or Laser Notice.

Laser products that are used for medical applications must also comply with the medical device regulations. For more information, see: Overview of Device Regulation.

fda lcd monitors for import made in china

The United States (U.S.) Food and Drug Administration (FDA) is responsible for ensuring that medical devices (including in vitro diagnostics) and radiation-emitting electronic products comply with applicable U.S. regulations when offered for importation into the United States. Foreign establishments must comply with these applicable regulations before, during, and after the medical device or radiation-emitting electronic product is imported into the United States or territory. FDA does not recognize regulatory authorizations from other countries. The product must meet the applicable FDA regulation.

FDA verifies and enforces applicable medical device requirements at the time a medical device is imported or offered for import into the United States. FDA’s Center for Devices and Radiological Health (CDRH) is responsible for overseeing the medical device program.

A foreign manufacturer is a manufacturer located outside of the United States. Foreign manufacturers must meet applicable U.S. regulations in order to import a device into the U.S.

A foreign manufacturer must designate a United States agent as a part of its initial and updated registration information. A foreign manufacturing site is subject to FDA inspection, medical device tracking (when required), and adverse event reporting.

An initial importer is defined in Title 21 Code of Federal Regulations (21 CFR) Part 807.3(g) as any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.

Under the MDR regulations, an importer is required to report incidents in which a device may have caused or contributed to a death or serious injury as well as certain malfunctions. An importer must maintain an MDR event file for each adverse event. All product complaints including MDR and non MDR events, must be forwarded to the manufacturer. Under the Medical Device Tracking regulation, certain devices must be tracked through the distribution chain.

A foreign manufacturer who imports a radiation-emitting electronic product into the United States must meet the radiation safety-related requirements of the Federal Food, Drug, and Cosmetic Act, Subchapter C: Electronic Product Radiation Control. These requirements include: performance standards, labeling, and submission of radiation safety product reports.

A foreign manufacturer submits a radiation safety product report to FDA for review. Upon receipt, FDA assigns the report an accession number. An accession number is a unique identifier for the product safety report maintained in an FDA database. An importer may submit a radiation safety product report on behalf of a foreign manufacturer.

An importer may submit a radiation safety product report on behalf of a manufacturer. An importer of a radiation-emitting electronic product subject to a performance standard is required to send to FDA a written declaration on “Declaration of Products Subject to Radiation Control Standards,” Form FDA 2877. The importer must also provide import entry information, including an accession number, if appropriate, through U.S. Customs and Border Protection (CBP) to FDA.

All medical devices imported into the United States (U.S.) must meet the regulatory requirements of both the U.S. Bureau of Customs and Border Protection (CBP) and FDA. Products that do not meet FDA regulatory requirements may be detained upon entry.

CBP administers the Tariff Act of 1930 as amended. The primary duties include: assessment and collection of all duties, taxes, and fees on imported merchandise, administering and reviewing import entry forms, enforcing CBP and related laws, and administering certain navigation laws and treaties. FDA and CBP have an agreement for the cooperative enforcement of the Food, Drug, and Cosmetic Act, Section 801, Title 21 U.S.C. 381.

An entry for an FDA regulated product that is filed with CBP, will also be electronically submitted to FDA for review. An importer or customs broker is required to submit required entry information to CBP through the Automated Commercial Environment (ACE) system.

The HTS code is a classification code used to provide the applicable tariff rates and statistical categories for items imported into the U.S. For questions and guidance on tariff rates, please contact your local CBP Port of Entry.

You may expedite the entry review process by submitting accurate and complete information at the time of filing and by responding to requests for additional information in a timely manner.

An entity may import (bring into the United States) device parts, components, subassemblies, etc., for further processing or incorporation into unapproved devices which are to be subsequently exported (brought outside of the United States). An entity may notimport a finished device that is not legally marketed in the United States, even if the device is to be imported into the United States solely for subsequent export. A finished medical device that is legally marketed in the United States has a Premarket Notification [510(k)] clearance, a De Novo granted, a Premarket Approval application approval, or is exempt. An entity may not use the “Import for Export” provision for warehousing articles in the United States.

A personal importation is the import of an up-to-90-day supply of a medical device not for further sale or distribution into the United States. These devices may be carried in a baggage or shipped by courier or international mail. Drop shipping is the importation of a U.S. legally marketed device for one person.

fda lcd monitors for import made in china

WASHINGTON — In her first two years as Food and Drug Administration commissioner, Dr. Margaret A. Hamburg has repeatedly expressed alarm about waves of imported food and drugs overwhelming her organization’s ability to monitor them. But she had not provided a strategy to deal comprehensively with this problem — until now.

On Monday, the F.D.A. released a rare special report titled “Pathway to Global Product Safety and Quality” that is likely to win praise not so much for the four “building blocks” it outlines for dealing with imports but for the frank way it acknowledges the problem.

“This report in large part is meant to frame the issue so that all of our colleagues inside the F.D.A. and external to the F.D.A. really understand how much the world has changed, and the necessity of how much we do business in the F.D.A. has to be dramatically transformed,” Dr. Hamburg said in an interview. “This is something that I’ve been stressing as a priority from Day 1.”

A decade ago, the F.D.A. was responsible for policing six million shipments annually coming through 300 ports. This year, the number of shipments is expected to grow to 24 million, the report noted. Nearly two-thirds of all fruits and vegetables and three-quarters of all seafood consumed in the United States now come from outside the country.

The situation with drugs and medical devices is even more daunting. More than 80 percent of the active ingredients for drugs sold in the United States are made abroad — mostly in plants in China and India that are rarely inspected by the F.D.A. Half of all medical devices sold in the United States are made abroad. Many kinds of antibiotics, steroids, cancer medicines and even aspirin are no longer produced in the United States, or in many cases anywhere in the Western world.

Government investigators estimated in 2008 that the F.D.A. would need 13 years to check every foreign drug manufacturing plant, 27 years to check every foreign medical device plant and 1,900 years to check every foreign food plant at its rate of inspections at the time. And with imports growing faster than the agency’s inspection force, those numbers have only mounted.

Many popular over-the-counter medicines and vitamins are made almost entirely in Chinese plants that the F.D.A. has never inspected. Domestic suppliers often maintain that they test their imported ingredients rigorously, but such sampling is akin to testing a bucket of soil from a mountain, then declaring the entire mountain free of pollutants.

And once these products reach American shores, almost nothing is done. The F.D.A. has a few hundred inspectors — not even enough for every port. The most they know about the vast majority of imports is a brief description on a computer screen. They crack open a tiny fraction of all shipments and send to the agency’s laboratories an even tinier fraction. Less than one pound in a million of imported seafood even gets a visual inspection.

The F.D.A. won new powers to police foreign foods in legislation signed by President Obama in January, but with those new powers came new responsibilities. The law directed the agency to inspect at least 600 foreign food facilities within a year, then increase that number every year afterward. But instead of increasing the agency’s budget to perform those inspections, House Republicans voted last week to cut it.

“While the goal may be attainable in the first year, it would be impossible for F.D.A. to complete 19,200 foreign food inspections in year six without a substantial increase in resources or a complete overhaul in the way it operates,” the report notes.

Many in the food industry, angered by contamination scares that have cost hundreds of millions of dollars, have volunteered to pay fees directly to the F.D.A. to underwrite more inspections. Consumer groups have cheered this suggestion. But some Republicans in the Senate have so far refused to consider such fees, calling them an unacceptable tax. Polls have shown overwhelming and bipartisan support among voters for strengthened federal oversight of the food system.

So in the absence of the people and money needed to perform the agency’s functions adequately today, Dr. Hamburg has proposed creating “global coalitions of regulators dedicated to building and strengthening the product safety net around the world,” the report states. To support this network, “F.D.A. intends to develop a global data information system” so regulators can talk to one another.

The F.D.A. already has some limited cooperation agreements with regulators in Europe and elsewhere, and it has recently stationed employees in China, India and Central America. Closer cooperation between the F.D.A. and European authorities, for instance, could spare manufacturers and governments the expense of repeated inspections of the same plants. And better sharing could allow the findings of an alarming audit by one country to alert others to problems.

Carl R. Nielsen, who retired as the director of the agency’s import operations in 2005, said the plan sounded reasonable as far as it went. But before the F.D.A. can consider communicating regularly with Brussels or Beijing, he said, it needs to start talking with its offices in Texas and California.

Indeed, a computerized alert system for imports that was started at the F.D.A. in 2001 is still not complete. But Dr. Hamburg said in the interview that despite possible budget cuts and challenges domestically, the agency has no choice in becoming more globally engaged. And just stepping up inspections at the border will not be enough, she said.

“It’s all very nice for people to feel that we have one of the safest food supplies in the world,” she said, repeating a phrase that House Republicans used to justify cutting the agency’s budget. “But we really need to recognize that our food is increasingly coming from this complex supply chain and coming from parts of the world where there are not as robust standards and practice. And we cannot be complacent.”

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Shenyang Xinsheng (New Life) Chemical Works, a/k/a Shenyang Dongbei Assistant Agent Main Factory, a/k/a Xinsheng Chemical Factory, a/k/a Shenyang No. 1 Laogai Detachment, a/k/a Shenyang Reform Through Labor Second Reform Division

fda lcd monitors for import made in china

The Federal Trade Commission (FTC) is charged with preventing deception and unfairness in the marketplace. The FTC Act gives the Commission the power to bring law enforcement actions against false or misleading claims that a product is of U.S. origin. Traditionally, the Commission has required that a product advertised as Made in USA be "all or virtually all" made in the U.S. After a comprehensive review of Made in USA and other U.S. origin claims in product advertising and labeling, the Commission announced in December 1997 that it would retain the "all or virtually all" standard. The Commission also issued an Enforcement Policy Statement on U.S. Origin Claims to provide guidance to marketers who want to make an unqualified Made in USA claim under the "all or virtually all" standard and those who want to make a qualified Made in USA claim.

This publication provides additional guidance about how to comply with the "all or virtually all" standard. It also offers some general information about the U.S. Customs Service’s requirement that all products of foreign origin imported into the U.S. be marked with the name of the country of origin.

This publication is the Federal Trade Commission staff’s view of the law’s requirements. It is not binding on the Commission. The Enforcement Policy Statement issued by the FTC is at the end of the publication.

The policy applies to all products advertised or sold in the U.S., except for those specifically subject to country-of-origin labeling by other laws. Other countries may have their own country-of-origin marking requirements. As a result, exporters should determine whether the country to which they are exporting imposes such requirements.

The Enforcement Policy Statement applies to U.S. origin claims that appear on products and labeling, advertising, and other promotional materials. It also applies to all other forms of marketing, including marketing through digital or electronic mechanisms, such as Internet or e-mail.

In identifying implied claims, the Commission focuses on the overall impression of the advertising, label, or promotional material. Depending on the context, U.S. symbols or geographic references (for example, U.S. flags, outlines of U.S. maps, or references to U.S. locations of headquarters or factories) may convey a claim of U.S. origin either by themselves, or in conjunction with other phrases or images.

Example: A product is manufactured abroad by a well-known U.S. company. The fact that the company is headquartered in the U.S. also is widely known. Company pamphlets for its foreign-made product prominently feature its brand name. Assuming that the brand name does not specifically denote U.S. origin (that is, the brand name is not "Made in America, Inc."), using the brand name by itself does not constitute a claim of U.S. origin.

The Commission does not pre-approve advertising or labeling claims. A company doesn’t need approval from the Commission before making a Made in USA claim. As with most other advertising claims, a manufacturer or marketer may make any claim as long as it is truthful and substantiated.

For a product to be called Made in USA, or claimed to be of domestic origin without qualifications or limits on the claim, the product must be "all or virtually all" made in the U.S. The term "United States," as referred to in the Enforcement Policy Statement, includes the 50 states, the District of Columbia, and the U.S. territories and possessions.

"All or virtually all" means that all significant parts and processing that go into the product must be of U.S. origin. That is, the product should contain no — or negligible — foreign content.

The product’s final assembly or processing must take place in the U.S. The Commission then considers other factors, including how much of the product’s total manufacturing costs can be assigned to U.S. parts and processing, and how far removed any foreign content is from the finished product. In some instances, only a small portion of the total manufacturing costs are attributable to foreign processing, but that processing represents a significant amount of the product’s overall processing. The same could be true for some foreign parts. In these cases, the foreign content (processing or parts) is more than negligible, and, as a result, unqualified claims are inappropriate.

Example: A company produces propane barbecue grills at a plant in Nevada. The product’s major components include the gas valve, burner and aluminum housing, each of which is made in the U.S. The grill’s knobs and tubing are imported from Mexico. An unqualified Made in USA claim is not likely to be deceptive because the knobs and tubing make up a negligible portion of the product’s total manufacturing costs and are insignificant parts of the final product.

Example: A table lamp is assembled in the U.S. from American-made brass, an American-made Tiffany-style lampshade, and an imported base. The base accounts for a small percent of the total cost of making the lamp. An unqualified Made in USA claim is deceptive for two reasons: The base is not far enough removed in the manufacturing process from the finished product to be of little consequence and it is a significant part of the final product.

Should manufacturers and marketers rely on information from American suppliers about the amount of domestic content in the parts, components, and other elements they buy and use for their final products?

If given in good faith, manufacturers and marketers can rely on information from suppliers about the domestic content in the parts, components, and other elements they produce. Rather than assume that the input is 100 percent U.S.-made, however, manufacturers and marketers would be wise to ask the supplier for specific information about the percentage of U.S. content before they make a U.S. origin claim.

Example: A company manufactures food processors in its U.S. plant, making most of the parts, including the housing and blade, from U.S. materials. The motor, which constitutes 50 percent of the food processor’s total manufacturing costs, is bought from a U.S. supplier. The food processor manufacturer knows that the motor is assembled in a U.S. factory. Even though most of the parts of the food processor are of U.S. origin, the final assembly is in the U.S., and the motor is assembled in the U.S., the food processor is not considered "all or virtually all" American-made if the motor itself is made of imported parts that constitute a significant percentage of the appliance’s total manufacturing cost. Before claiming the product is Made in USA, this manufacturer should look to its motor supplier for more specific information about the motor’s origin.

Example: On its purchase order, a company states: "Our company requires that suppliers certify the percentage of U.S. content in products supplied to us. If you are unable or unwilling to make such certification, we will not purchase from you." Appearing under this statement is the sentence, "We certify that our ___ have at least ___% U.S. content," with space for the supplier to fill in the name of the product and its percentage of U.S. content. The company generally could rely on a certification like this to determine the appropriate country-of-origin designation for its product.

To determine the percentage of U.S. content, manufacturers and marketers should look back far enough in the manufacturing process to be reasonably sure that any significant foreign content has been included in their assessment of foreign costs. Foreign content incorporated early in the manufacturing process often will be less significant to consumers than content that is a direct part of the finished product or the parts or components produced by the immediate supplier.

Example: The steel used to make a single component of a complex product (for example, the steel used in the case of a computer’s floppy drive) is an early input into the computer’s manufacture, and is likely to constitute a very small portion of the final product’s total cost. On the other hand, the steel in a product like a pipe or a wrench is a direct and significant input. Whether the steel in a pipe or wrench is imported would be a significant factor in evaluating whether the finished product is "all or virtually all" made in the U.S.

Example: If the gold in a gold ring is imported, an unqualified Made in USA claim for the ring is deceptive. That’s because of the significant value the gold is likely to represent relative to the finished product, and because the gold — an integral component — is only one step back from the finished article. By contrast, consider the plastic in the plastic case of a clock radio otherwise made in the U.S. of U.S.-made components. If the plastic case was made from imported petroleum, a Made in USA claim is likely to be appropriate because the petroleum is far enough removed from the finished product, and is an insignificant part of it as well.

A qualified Made in USA claim is appropriate for products that include U.S. content or processing but don’t meet the criteria for making an unqualified Made in USA claim. Because even qualified claims may imply more domestic content than exists, manufacturers or marketers must exercise care when making these claims. That is, avoid qualified claims unless the product has a significant amount of U.S. content or U.S. processing. A qualified Made in USA claim, like an unqualified claim, must be truthful and substantiated.

Example: An exercise treadmill is assembled in the U.S. The assembly represents significant work and constitutes a "substantial transformation" (a term used by the U.S. Customs Service). All of the treadmill’s major parts, including the motor, frame, and electronic display, are imported. A few of its incidental parts, such as the handle bar covers, the plastic on/off power key, and the treadmill mat, are manufactured in the U.S. Together, these parts account for approximately three percent of the total cost of all the parts. Because the value of the U.S.-made parts is negligible compared to the value of all the parts, a claim on the treadmill that it is "Made in USA of U.S. and Imported Parts" is deceptive. A claim like "Made in U.S. from Imported Parts" or "Assembled in U.S.A." would not be deceptive.

Claims that a particular manufacturing or other process was performed in the U.S. or that a particular part was manufactured in the U.S. must be truthful, substantiated, and clearly refer to the specific process or part, not to the general manufacture of the product, to avoid implying more U.S. content than exists.

In addition, if a product is of foreign origin (that is, it has been substantially transformed abroad), manufacturers and marketers also should make sure they satisfy Customs’ markings statute and regulations that require such products to be marked with a foreign country of origin. Further, Customs requires the foreign country of origin to be preceded by "Made in," "Product of," or words of similar meaning when any city or location that is not the country of origin appears on the product.

Example: A company designs a product in New York City and sends the blueprint to a factory in Finland for manufacturing. It labels the product "Designed in USA — Made in Finland." Such a specific processing claim would not lead a reasonable consumer to believe that the whole product was made in the U.S. The Customs Service requires the product to be marked "Made in," or "Product of" Finland since the product is of Finnish origin and the claim refers to the U.S. Examples of other specific processing claims are: "Bound in U.S. — Printed in Turkey." "Hand carved in U.S. — Wood from Philippines." "Software written in U.S. — Disk made in India." "Painted and fired in USA. Blanks made in (foreign country of origin)."

Example: A computer imported from Korea is packaged in the U.S. in an American-made corrugated paperboard box containing only domestic materials and domestically produced expanded rigid polystyrene plastic packing. Stating Made in USA on the package would deceive consumers about the origin of the product inside. But the company could legitimately make a qualified claim, such as "Computer Made in Korea — Packaging Made in USA."

Example: The Acme Camera Company assembles its cameras in the U.S. The camera lenses are manufactured in the U.S., but most of the remaining parts are imported. A magazine ad for the camera is headlined "Beware of Imported Imitations" and states "Other high-end camera makers use imported parts made with cheap foreign labor. But at Acme Camera, we want only the highest quality parts for our cameras and we believe in employing American workers. That’s why we make all of our lenses right here in the U.S." This ad is likely to convey that more than a specific product part (the lens) is of U.S. origin. The marketer should be prepared to substantiate the broader U.S. origin claim conveyed to consumers viewing the ad.

Comparative claims should be truthful and substantiated, and presented in a way that makes the basis for comparison clear (for example, whether the comparison is to another leading brand or to a previous version of the same product). They should truthfully describe the U.S. content of the product and be based on a meaningful difference in U.S. content between the compared products.

Example: An ad for cellular phones states "We use more U.S. content than any other cellular phone manufacturer." The manufacturer assembles the phones in the U.S. from American and imported components and can substantiate that the difference between the U.S. content of its phones and that of the other manufacturers’ phones is significant. This comparative claim is not deceptive.

Example: A product is advertised as having "twice as much U.S. content as before." The U.S. content in the product has been increased from 2 percent in the previous version to 4 percent in the current version. This comparative claim is deceptive because the difference between the U.S. content in the current and previous version of the product are insignificant.

A product that includes foreign components may be called "Assembled in USA" without qualification when its principal assembly takes place in the U.S. and the assembly is substantial. For the "assembly" claim to be valid, the product’s last "substantial transformation" also should have occurred in the U.S. That’s why a "screwdriver" assembly in the U.S. of foreign components into a final product at the end of the manufacturing process doesn’t usually qualify for the "Assembled in USA" claim.

Example: A lawn mower, composed of all domestic parts except for the cable sheathing, flywheel, wheel rims and air filter (15 to 20 percent foreign content) is assembled in the U.S. An "Assembled in USA" claim is appropriate.

Example: All the major components of a computer, including the motherboard and hard drive, are imported. The computer’s components then are put together in a simple "screwdriver" operation in the U.S., are not substantially transformed under the Customs Standard, and must be marked with a foreign country of origin. An "Assembled in U.S." claim without further qualification is deceptive.

The Tariff Act gives Customs and the Secretary of the Treasury the power to administer the requirement that imported goods be marked with a foreign country of origin (for example, "Made in Japan").

When an imported product incorporates materials and/or processing from more than one country, Customs considers the country of origin to be the last country in which a "substantial transformation" took place. Customs defines "substantial transformation" as a manufacturing process that results in a new and different product with a new name, character, and use that is different from that which existed before the change. Customs makes country-of-origin determinations using the "substantial transformation" test on a case-by-case basis. In some instances, Customs uses a "tariff shift" analysis, comparable to "substantial transformation," to determine a product’s country of origin.

Even if Customs determines that an imported product does not need a foreign country-of-origin mark, it is not necessarily permissible to promote that product as Made in USA. The FTC considers additional factors to decide whether a product can be advertised or labeled

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