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FDA Suggests Manufacturing and Labeling Criteria for Children’s Laser Toys

On December 19, 2014, the U.S. Food and Drug Administration issued a final guidance document regarding children’s toys that contain laser beams.  In the guidance, FDA defines children’s laser toys and offers suggestions for both the manufacturing and labeling of laser toys.

FDA proposed a rule in June 2013 to define children’s laser toys and to require them to be manufactured within the IEC Class I emission limit, but the rule is still in the process of being finalized.  For now, the definition and suggestions in the guidance are solely FDA suggestion and are not supported by enforceable legal requirements.

Definition

FDA defines a “children’s toy laser product”  as “a product primarily used as a toy that is manufactured, designed, intended or promoted for novelty or visual entertainment use by children under 14 years of age.”  The agency excludes lasers that are used by children in a professional or academic setting from this definition.

Manufacturing

FDA believes that lasers have a higher chance of being used in an unsafe manner when in the hands of children.  The agency suggests that lasers used in children’s toys be kept within the FDA Class I or IEC Class I emission limits to minimize the risks they pose, such as retinal injury or skin burns, to those in range of the laser beam.  IEC Class I laser beams are safe for eyes, even when viewed directly for a long period of time.

Labeling

FDA recommends that laser toy labelers use IEC Class I designation labeling so that purchasers are aware of the minimal risk associated with the product.

While the previous suggestions for children’s laser toys are not enforced at this time, they may be in the near future.  Companies that wish to learn more about FDA’s regulations for laser products or need assistance with labeling a children’s laser toy should contact Registrar Corp.

About the Author: David Lennarz is Vice President of Registrar Corp, an FDA compliance firm located in Hampton, Virginia, USA.  Lennarz served as a Technical Expert for FDA’s Foreign Facility Registration Verification Program and has conducted seminars on U.S. FDA regulations in more than 30 countries around the world.

FDA Opens Inspection Data to Public in New Dashboard

On October 2, FDA announced on its blog a new data dashboard where users can view data regarding FDA inspections and enforcement.  The dashboard currently contains data for fiscal year (FY) 2009 to FY 2013, and FDA plans to update the database twice a year.  For now, the datasets only include final actions.  Some of the data was previously available on the FDA website in downloadable spreadsheets, but in the dashboard, the information is presented as graphs.

When you enter the dashboard, you have two options for how to view the data:

Reports and Trends

The reports and trends section of the dashboard references more general statistics, such as the breakdown of FDA inspection conclusion reports.  When FDA concludes an inspection it reports one of three things: Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI).  OAI means an FDA inspection revealed significant objectionable conditions or practices and action must be taken to address the issues.  VAI means FDA found objectionable conditions, but they did not warrant regulatory significance.  NAI means FDA found no objectionable conditions that warrant further action.

In the dashboard, users can see how many of each type of inspection conclusions were reported by each FDA center.  For example, in FY 2013, the Center for Food Safety and Applied Nutrition (CFSAN) reported significantly more NAI conclusions than OAI or VAI conclusions.  The Center of Drug Evaluation and Research (CDER), however, reported nearly the same number of VAI conclusions as NAI conclusions.

Inspections by Country

You can also view data in the dashboard more specifically by country.  You can see the number of inspections conducted in each country, and by clicking on a country, you can access more detailed information.  You can see the number and types of inspection conclusions reported in each country and the number of inspections conducted by each FDA center in each country.

According to the dashboard, the United States has undergone the most FDA inspections in the past 5 years, with its count at an outstanding 81,971.  Canada comes in second with 782 inspections, and China is a close third with 780.  Keep in mind that there are significantly more U.S. facilities registered with FDA than other countries.  Speaking of food facilities alone, over 80,000 U.S. food facilities are registered with FDA, while there are 6,433 Canadian food facilities registered with FDA.

It’s important to know that in 2011, the Food Safety Modernization Act (FSMA) directed FDA to increase the number of food facility inspections it conducts.  FSMA mandated that FDA inspect all high risk U.S. facilities by 2016 and again every three years thereafter.  FDA must inspect all non-high-risk U.S. facilities by 2018 and again every five years thereafter.   For foreign facilities, FDA must double the number of inspections it conducts every year through 2016.

Along with mandating that FDA increase the number of inspections, FSMA granted FDA the authority to collect reinspection fees.  Initial inspections cost nothing, but if the inspection reveals certain food safety issues and FDA decides to return, FDA will charge for every hour spent on the reinspection.  This includes the time it takes FDA to prepare for the reinspection and to travel to and from the facility. The cost for reinspections in FY 2015 is $217 per hour for domestic facilities and $305 per hour for foreign facilities.

With the new financial risks associated with FDA inspections, it’s a good idea to prepare in advance.  Registrar Corp offers a mock FDA inspection service for food facilities.  We will send a food safety expert trained in FDA inspections to a facility to help prepare.  If FDA sets a date for an inspection, this mock inspection service is offered free of charge to Registrar Corp’s U.S. Agent clients, other than travel and lodging expenses.

Registrar Corp is a consulting firm that helps companies comply with FDA regulations.   Along with mock inspections, we offer registration services and label reviews to food, drug, device, and cosmetic companies.  If you are interested in our services or have any questions regarding FDA regulations, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Specialist 24 hours a day at http://www.registrarcorp.com/livehelp.

*Note: Similarly in August, FDA revealed a new API that gives users access to drug labeling and enforcement statistics.

FDA Casts a Light on Radiation Emitting Devices

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

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

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

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

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

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

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

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

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

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

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

Shipment detained by FDA? Tips on how to best deal with a detention

An import “detention” occurs when FDA (or U.S. Customs and Border Patrol, acting for the FDA), in examining an FDA-regulated product offered for import, halts the entry for further examination. Further examination often requires laboratory analysis or scientific and technical data concerning the product. Import detentions are costly even where the product ultimately is released by FDA and allowed entry to the United States. The process delays shipments, complicates logistics and often adds storage costs. In addition, the Food Safety Modernization Act (FSMA), passed in 2011, authorizes FDA to charge importers and exporters for FDA’s costs in connection with some detentions.

Import “detentions” end in one of two ways. Either the product is released and allowed entry to the United States, or it is refused entry. An import “refusal” occurs when FDA determines that the product will not be allowed entry to the United States. At that point, the product must be shipped elsewhere or destroyed.

Obviously, importers and exporters should endeavor to avoid detentions, if possible. However, many detentions are unavoidable. If an imported product is detained, importers and exporters should take appropriate action so that FDA does not refuse entry.

For companies faced with a detention, it is critical to act properly. We recommend the following immediate actions:

1) First, gather the facts about the detention. Do not argue with FDA or the inspector who detained your product. Do not respond to the detention charges until you have gathered all of the facts about the detention and are aware of the FDA’s concerns. Be aware that it may be impossible for you to objectively view the situation from the position of the FDA inspector who detained your product and that you may not know all the nuances of a particular FDA regulatory requirement. Failure to appreciate the nuances of FDA detentions could cause you to inadvertently make matters worse. If the shipment has more than nominal value, it is worthwhile to retain a professional consultant familiar with the FDA and its procedures (like Registrar Corp) to assist with your detention, rather than attempt to resolve the issue without such assistance. Note to non-U.S. exporters: If you have retained Registrar Corp as your facility’s U.S. Agent for FDA communications, assistance with detentions may be provided at no additional cost (depending on the reason for the detention); simply contact your Registrar Corp Regulatory Adviser as soon as you learn the shipment is detained. Please contact Registrar Corp before you speak with FDA about the detention.

2) Upon detaining a shipment, FDA will issue a written document called the “Notice of Action” to the importer of record and to the customs broker who filed the entry. The Notice of Action will present the formal reasons why the products have been detained and will identify which section of the law FDA charges may have been violated. These are the detention charges to which you must respond — with documentary proof, not bombast. As shown by the statistics released by FDA (see December 8th blog), FDA may release detained products upon receipt of sufficient proof rebutting the charge stated by the Notice of Action. The Notice of Action will set a deadline for your response, called the “Respond By” date. That deadline should be taken seriously. If it passes without extension, it will be too late to avoid refusal even for admissible goods!

3) Contact Registrar Corp for immediate assistance, even if Registrar Corp is not designated as U.S. Agent for your facility. Simply phone: +1-757-224-0177 or contact via Live Help: http://www.registrarcorp.com/livehelp

 

FDA Guidance for Expediting Entry Review Process

On September 6, 2011 the Food and Drug Administration issued a letter with recommendations to help expedite the entry review process for medical and non-medical radiation-emitting electronic products. In this letter the FDA has noted that Affirmation of Compliance (AofC) codes should be provided at the time of entry to the U.S. and that appropriately submitted AofC codes will not only expedite the admissibility process but will also increase the likelihood that your shipment is not held for further entry review by FDA personnel.

In this letter the FDA has asserted that importers of these products work very closely with their brokers, filers, and other import personnel to verify that the information submitted is accurate and that the correct product codes are entered. The FDA has warned that “inaccurate or inconsistent data may lead to delays”. Furthermore, the AofC codes should be submitted with the relevant qualifier to the FDA and U.S. Customs and Border Protection.

Additionally, CBP regulations compel importers to note whether or not their products comply with federal performance standards. The FDA works with CBP by providing Form  FDA-2877, Declaration for Imported Electronic Products Subject to Radiation Control Standards, which must be filled out by the importer. Moreover, radiation-emitting devices are also subject to regulation by the Center for Devices and Radiological Health (CDRH) and are subject to federal performance standards. However, there are medical radiation-emitting electronic products that have reporting requirements under 21 CFR 1002 but are not subject to federal performance standards, in which case, Form FDA-2877 is not required.

On the whole, importers, brokers, filers, and other import personnel should take extra care to ensure correct AofC codes that are applicable to medical devices and radiation-emitting electronic products. If you have further questions about importing your medical and non-medical radiation-emitting electronic product, Registrar Corp is available for discussion by phone at +1-757-224-0177or 24/7 via online Live Help. To receive U.S. FDA regulatory updates, visit:  http://www.registrarcorp.com/fda-updates

Registrar Corp Now Offers Services for Radiation Emitting Devices

Registrar Corp now provides Reporting, U.S. Agent, and Regulatory Compliance Assistance for U.S. and Non-U.S. Companies in the Radiation-Emitting Electronic Device Industry.

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

Examples of Radiation-Emitting Electronic Devices may include, but are not limited to, microwave ovens, televisions receivers and monitors, video displays, lasers, industrial x-ray systems, cordless and cellular telephones, industrial RF sealers of plastics and laminates, or laser CD players.

Some Radiation-Emitting Electronic Devices, such as diagnostic x-rays, ultrasound imaging devices, microwave or ultrasound diathermy devices, microwave blood warmers or sterilizers, laser coagulators, ultrasound phacoemulsifiers, x-ray or electron accelerators, sunlamps, or ultraviolet dental curing devices, are regulated by the U.S. FDA as both a Radiation-Emitting Electronic Device and as a Medical Device.

For information about how your product is regulated by the U.S. FDA, contact us and one of our expert regulatory advisers will assist you.





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