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This page will provide an overview of medical and non-medical radiation-emitting electronic products and the requirements that FDA verifies/enforces at the time they are imported or offered for import into United States.  To import radiation-emitting products (medical and non-medical) you should first understand what these products are and their requirements.

The Center for Devices and Radiological Health (CDRH) is the FDA center responsible for overseeing the radiation-emitting products program.  Visit the Radiation-Emitting Products web page for more information.

FDA defines a radiation-emitting electronic product as any electrically-powered product that can emit any form of radiation on the electromagnetic spectrum. These include a variety of medical and non-medical products such as mammography devices, magnetic resonance imaging (MRI) devices, laser toys, laser pointers, liquid crystal displays (LCDs), and light emitting diodes (LEDs).  View examples of radiation-emitting electronic products.

FDA checks the import alert database to ensure the manufacturer or product is not subject to detention without physical exam (DWPE) and listed on an import alert.  For example, import alert 95-04 lists certain laser products that fail to comply with applicable performance standards and reporting requirements.

Electronic products are subject to the Electronic Product Radiation Control (EPRC) provisions as defined in the Federal Food Drug and Cosmetic Act (FD&C Act), Chapter 5, Subchapter C, Sections 532 – 538.  Radiation-emitting electronic products are regulated by FDA and are required to comply with the general requirements found in 21 CFR 1000-1005.    For more information on products subject to performance standards visit the Products Subject to Performance Standards page.

To search for product names and their associated product codes, the radiation type, definition, and applicable performance standards visit the Product Codes for Radiation-Emitting Electronic Products page.

FDA Entry Reviewers are trained to verify compliance with applicable product requirements. The FDA Entry Reviewers use the information provided to FDA in the importer’s entry transmission such as:

These entry declarations are compared to information in FDA’s internal data systems. If the information matches, then compliance is verified; if the information does not match, FDA may gather additional information or may detain the product.

The submission of correct and accurate entry data along with the relevant A of C codes will help expedite the entry review process. Supplying this information accurately increases the likelihood that your shipment will be processed electronically and not held for manual review because FDA’s screening tool, PREDICT, can verify the declared information against FDA internal data systems.

Radiation-emitting electronic products can be considered medical and non-medical products.  In addition to the requirements above, radiation-emitting electronic medical products are also subject to medical device regulations. At the time of importation FDA will verify radiation-emitting electronic product requirements (medical and non-medical).

Radiation-emitting electronic products subject to U.S. Federal Performance Standard require submission of Form FDA-2877, Declaration for Imported Electronic Products Subject to Radiation Control Standards, at the time of entry. Products not subject to federal performance standards do not require a Form FDA-2877 for importation into the US.  At the time of importation FDA will verify the declarations submitted on Form FDA-2877.

Declaration C – Products that do not comply with performance standards are being held under temporary import bond (TIB); will not be introduced into commerce; will be used under a radiation protection plan; and will be destroyed or exported under CBP supervision when the mission is complete.

Declaration D - Products that do not comply with Performance Standards; are being held and will remain under bond; and will not be introduced into commerce until notification is received from FDA that the products have been brought into compliance in accordance with an FDA approved petition.

The process of “reconditioning” non-compliant radiation-emitting electronic products may be difficult and time consuming which could result in the importer losing the product and money if the reconditioning is unsuccessful. The importer should make a serious effort to understand the FDA radiation safety requirements that are applicable to the products being imported. Reconditioning requests are submitted using the Form FDA-766.

Affirmation of Compliance (A of C) codes are three letter codes that can be provided at the time of import to facilitate FDA review.  FDA uses A of C codes to assist in verifying that your product meets the appropriate requirements.  Providing the correct A of C code reduces the likelihood that your shipment will be held for further FDA entry review during FDA’s import screening process. Submission of A of C codes is only mandatory in some instances and is not required for all scenarios. Submitting voluntary A of C codes in addition to all mandatory A of C codes may expedite initial screening and review of your entry.

For information on affirmation of compliance codes refer to the “Affirmation Of Compliance References”  at the bottom of the affirmation of compliance codes page.

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:

If you are planning on importing any device that is or consists of a tablet or a display screen, take heed of regulatory obstacles that might stand in your way.  Since both tablets and display screens often emit radio noise and small amounts of radiation, these devices must comply with Federal Communications Commission (FCC) and the Federal Drug Administration (FDA) standards.  In other words, all screen and tablet importers must be certified under both government bodies before importing their products.

The first step, however, is to determine the official classification of your tablet or display screen.  The Harmonized Tariff Schedule is the database to find the customs duties that will apply to your product.  Below are some tips on how to import your tablet or screen in accordance with FCC and FDA regulations and standards:

Since tablets are distributed for consumer use, they fall under FCC Class B categorization. Tablets and screens are classified as “non-licensed, low-power transmitters,” and fortunately consumers do not need a license from the FCC to use them. However, those importing them will need to get them FCC-certified for safety.

To obtain FCC certification for a product, you need to submit the device for testing at an FCC-authorized lab.  Then, the product must be tagged with a compliance label along with an FCC ID (which can be created with a grantee code and a product code).  Finally, you can submit the testing results and device specifications, along with the proper labels, to the FCC for approval and they will send you a grant of certification.

Tablets and screens also fall under FDA regulation since they include lasers, LED, or Intense Pulsed Lights, which emit potentially harmful radiation.  While the FDA does not technically need to grant approval for products, they do have the right to ban products or order for changes in a device if they do not meet FDA standards.  For this reason, importers or manufacturers need to test and certify a product themselves to meet those standards.  However, though products are not officially FDA approved, some products – such as medical devices – will require importers to submit reports, which can be done electronically at the FDA’s eSubmitter site.  Only after the submission is received will the FDA issue an accession number, which will certify that the product can be marketed commercially.

Importers will also be required to submit a Form FDA 2877 with the accession number and the importing paperwork to Customs and the FDA imports office when their shipment enters the US.  As long as the products are labeled and certified properly and the paperwork is in good order, the importing process will go smoothly.

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FDA has established electronic product performance standards in its regulations covering several varieties of radiation-emitting electronic products. Companies that manufacture or import electronic products subject to an FDA performance standard are required to submit various electronic product reports, the most basic and essential of which is the Electronic Product Initial Report.

When a manufacturer or importer submits an Electronic Product Initial Report, FDA’s Center for Devices and Radiological Health (CDRH) reviews the electronic product report to ensure the information demonstrates that the manufacturer’s electronic product meets any applicable performance standard and that the process for manufacturing or assembling the electronic product is likely to repeatedly produce complying electronic products. CDRH issues an Accession Numbers to the manufacturer that submitted the electronic product report, and that Accession Number is necessary for importing electronic products into the U.S.

FDA requires importers to provide the Accession Numbers on Form 2877. This is the one assigned by FDA to the manufacturers who made the imported electronic products. FDA import entry reviewers, investigators, and compliance officers use it to confirm that a foreign manufacturer or assembler has at least complied with the most basic FDA regulations governing electronic products: the filing of the electronic product report for the FDA review.

Accession numbers are proprietary information only known to FDA and the company that originally filed the report. As such, there is no public database where you can simply look up the accession numbers for products you are importing. This means that you must ask the manufacturer to reveal their accession numbers to you when FDA demands it upon entry into the United States.

There are also specific certification and labeling requirements that apply to electronic products, and the user manual is a critical piece of information for consumers. FDA requires electronic product user manuals to include many specific warnings and declarations, as well as include clear and concise instructions for use.

FDAImports prepares and files electronic product reports for many different technologies and has former CDRH reviewers ready to assist your company in obtaining new Accession Numbers. We can also help manage the importation process and properly respond to FDA notices or correspondence requests.

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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.

FDA published a variety of warning letters this week including from the Center for Tobacco Products and two more regarding the Foreign [Food] Supplier Verification Program and failure to comply with those requirements (we covered one of the earlier FSVP warning letters here).

FDA also posted four GMP drug warning letters, all to firms outside the US.  One of the letters reinforces the need to monitor import alerts to ensure that suppliers and CMOs are not on the list; the consequences of missing this can be serious as this firm learned.

The firm doesnot exercise appropriate controls over computer systems. The GC in the laboratory is mentioned whereadmin privileges are assigned to analysts. In reviewing audit trails, FDA investigators found that more than100 test results had been deletedsince October 2017 andmore than 100 sample sets were abortedin the same timeframe, all without investigation. FDA states: “Your quality system does not adequately ensure the accuracy and integrity of the data to support the safety, effectiveness and quality of the drugs you manufacture. Without complete and accurate records, you cannot assure appropriate decisions regarding batch release, product stability, and other matters that are fundamental to ongoing assurance of quality.”FDA found fault with the firm’s response because they did not commit to assess GC data related to all batches of product distributed to the US, did not commit to an independent review of why these practices occurred and what decisions led to data deletion. Note again the requirement for an “independent review”where it appears that the FDA does not trust the firm to perform this activity accurately.

The firm has not qualified equipment used in manufacture and thus there is no guarantee that it is suitable for its intended use and implicates the quality of all products made using this equipment.

The firm failed to validate the excel spreadsheet used in calculate assay results. Procedures did not provide instruction on how to verify the calculations. Further, the investigator identified a calculation error: the incorrect formula for averaging the Internal standard was used. FDA also states: “There is no assurance that the associated assay results recorded are reliable and accurate…your computerized systems must perform their functions satisfactorily and that your firm establish a written program to ensure ongoing proper system performance.”

FDA reminds the firm about its responsibilities as a contract manufacturer and that they are responsible for the quality of drugs they produce regardless of any agreement they may have with their client.

FDA states: “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.”

Some products contain glycerin and FDA is concerned that the firm may not be appropriately testing for the presence of a contaminant diethylene glycol.

CGA Limited (Trinidad & Tobago) received awarning letteron December 19, 2019, based on the outcome of an inspection ending May 31, 2019. The firm manufacturesOTC drug products, and one of their soap products is anunapproved new drug. FDA recommends the firm hire a consultant to assist them in coming into GMP compliance. FDA placed the firm onImport Alert66-40 on November 21, 2019.

The firm did not test incoming components for identityand other quality attributes, particularly identity and impurity testing according to USP.The firm stated they did not have the capability to perform the required testing and will contract an external lab to complete testing on the API. FDA deemed their response to be inadequate because the API testing was not described nor did the firm describe how they would qualify suppliers and validate their test results, including qualification of the contract laboratory.

Though this deficiency is well redacted it appears to address a water production and distribution system that is not adequately qualified, validated, and monitored to produce water that is suitable for use in the manufacture of drug products.

Zhuhai Aofute Medical Technology Co., Ltd(China) received awarning letteron January 9, 2020, based on the outcome of an inspection ending July 18, 2019.  The firm manufacturesOTC drug productsincluding “Magic Spray for Pain Relief” which is adulterated, an unapproved new drug, and misbranded—the enforcement trifecta in classification. The firm was placed onImport Alert66-40 on November 13, 2019. FDA recommends the firm hire aqualified consultantto assist them in coming into GMP compliance.FDA also recommends that the qualified consultant perform a comprehensive audit of the entire operation for CGMP compliance and that the consultant evaluates the completion and efficacy of corrective actions and preventive actions before the firm pursues resolution of its compliance status with FDA.

The firm failed to test identity and strength of each lot of productreleased for distribution. During the audit, staff stated theydid not evaluate the suitability of incoming raw materials and componentseither.

The firm does not have an independent, effective Quality Unit. For example, they failed to approve or reject all components and materials, failed to review all production and laboratory records, failed to assure adequate batch records and failed to approve procedures and specifications. Further, the firm does not have adequate production and laboratory records, and in fact,no meaningful production records existed. The firm also said theyroutinely discarded original raw data. And last but not least the Quality Unit was not independent of the manufacturing area.

Cosmelab Co Ltd(South Korea) received awarning letteron January 9, 2020, based on the outcome of an inspection ending July 17, 2019. The firm manufacturesOTCdrug products. FDA placed the firm on Import Alert 66-40 on November 12, 2019. The firm is cited for having firms on their suppliers list who have been placed on Import Alertby FDA. FDA states that“…your use of this supplier on Import Alert 66-40 led to the appearance of adulteration of your drugs.” FDA suggests the firm hire a qualified consultant to assist them in coming into GMP compliance. The warning letter includes only one deficiency, failure to establish an adequate Quality Unit, with multiple examples of failure to comply with GMPs.

The firmfailed to establish an adequate Quality Unit. Examples include but are not limited to failure to conduct and review assay tests prior to distribution of drug product, and release of drug product manufactured by acontract manufacturer that is on Import Alert 66-40. Further, the firm being inspected was unaware that their CMO was on Import Alert. FDA stated “…that a lack of understanding of FDA drug regulations contributed to your not establishing a dedicated quality unit. You committed to hire a consultant knowledgeable about FDA regulations.” Note again the FDA asks for an “independent assessment” indicating that they don’t feel the firm is capable of conducting a valid and effective assessment.

With more than 195 countries managing imports and exports across the global supply chain, introducing food and beverages into the United States comes with its own unique set of FDA regulations. Understanding and adhering to the regulations for each country can trigger knowledge gaps and spawn uncertainty. Do you need to focus on direct U.S. imports? Employing a holistic import strategy can ensure your goods arrive on time.

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Foreign Supplier Program ViolationsThe FDA continues to issue warning letters to importers concerning noncompliance with requirements under the Foreign Supplier Verification Program, which requires importers to perform certain risk-based activities to verify that the human and/or animal food they import has been produced in a manner that meets applicable U.S. food safety standards.

Most recently, FDA inspections of the facilities of one importer found that it failed to develop, maintain, and follow an FSVP for fresh enoki mushrooms. The FDA has given the importer 15 working days to provide information on the specific things it is doing to correct this violation; e.g., documentation of changes made and records to demonstrate implementation of an FSVP. If the importer does not act promptly the FDA may take further action, such as refusing admission of violative products and subjecting the importer to detention without physical examination.

The FDA notes that the mushrooms at issue have already been placed under two import alerts and that this information should be taken into consideration when the importer evaluates its suppliers and develops its FSVP.

Import Alerts: Cookware, Medical Instruments, Seafood, ProduceFDAimport alertsaffecting the following have been newly issued or modified in the past week.

Import alerts inform FDA field staff that the agency has enough evidence or other information to allow a product that appears to be in violation of FDA laws and regulations to be detained without physical examination at the time of entry. Import alerts may cover products from designated countries or areas (including from all foreign countries), manufacturers, or shippers.

Firms and/or products on the “red list” of an import alert are subject to Detention without Physical Exam (DWPE), while firms and/or products on the “green list” are not because they have met the criteria for exclusion. Some import alerts include a “yellow list” of firms, products, and/or countries subject to intensified surveillance because the nature of the violations may warrant further field examinations of individual entries and/or additional analyses. In addition, depending on the specific import alert, shipments of products subject to DWPE may still be imported into the U.S. if the importer has demonstrated that the shipment is in compliance.

If a product is detained without physical examination the importer has the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If no such evidence is submitted, or if the evidence provided is insufficient, the product will be subject to refusal of entry into the U.S.

Question:I work for an importer/exporter of industrial lifting equipment. Upon import, some of our goods are flagged for potential FDA reporting. We do import some products with lasers, leds and radiation emitting products. Is there a worksheet that someone would be willing to share as to how they determine if the product needs an FDA […]

Question:Regarding Marking Requirements with a Twist (for CBP and FDA Purposes) I work for a USA company.  Recently our Canada office placed an order with our Mexico office (bear in mind the USA is not involved in the transaction).  The Canada office purchases some bulk foodstuff from Mexico and asks Mexico to ship to a […]

Question: We have been trying to import a few different types of products that havebeen flagged FD2 by the FDA based on the product’s Harmonized Tariff Schedulecode. All of our products are intended for “Research Use Only” (as we are a Biotechcompany) and should not be regulated by the FDA.  Because of the FD2 Flag,our […]

Question:We have been trying to import a few different types of products that have been flagged FD2 by the FDA based on the product’s Harmonized Tariff Schedule code. All of our products are intended for “Research Use Only” (as we are a Biotech company) and should not be regulated by the FDA.  Because of the […]

Question:Am seeing increase in FDA inspections & holds. My customs broker tells me he’s seeing it across the board and we are not being singled out. Through rumor mill I’m told part of the reason is FDA’s fiscal year starts Oct 1 and now that they have the budget for lab/inspection they are firing on […]

Question: Do most that work in the area of importing investigational drug products deal with their Regulatory Project Manager assigned by the FDA to the specific IND in regards to assistance with detailed import/export questions or to another specific contact?  Any agency specific contacts outside of the typical CDER Drug Information Specialists would be greatly […]

Question:Would anyone know how PREDICT handles foreign suppliers who are listed on import alerts for products they no longer produce? If, for example, a foreign supplier is on Import Alert 99-08 ( pesticides ) dating back to let’s say 1998 on a particular food item that they no longer produce and they’ve decided not to […]

Question:   My broker tells me I need to file a FDA 510K.  Never heard of the critter. Can’t say that I especially want to.  But, it looks like I need to hear about this thing need to. And the answers database comes back with a Zero.   So, here are my questions:   1 […]

Question: We’ve noticed a recent increase in FDA (food) exams on cargo arriving via the port of New York. Across the board on different products ( fruits to vegetables ) and different origins ( Europe, South America etc). Am curious to know if the membership is also seeing an increase. I know PREDICT is being […]

Question:Among the things I value in being a member of the ICPA is the community of practice established in reaching out to ask questions…even the embarrassing ones. With all the hoopla about the FDA’s Transparency Taskforce…I’m curious to know if I’m missing something or if I simply haven’t clicked the right link. As a responsible […]

Original Question: Am seeing increase in FDA inspections & holds. My customs broker tells me he’s seeing it across the board and we are not being singled out. Through rumor mill I’m told part of the reason is FDA’s fiscal year starts Oct 1 and now that they have the budget for lab/inspection they are […]

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