May 21, 2015 by David Lennarz
Filed under: FDA News |
On May 14, 2015, the U.S. Food and Drug Administration (FDA) hosted a webinar on the process of importing products to the United States. During the webinar, FDA discussed its system for determining which shipments to examine or sample before allowing them to enter the U.S., as well as best practices and common mistakes made when handling a detention.
Millions of dollars’ worth of FDA-regulated products are exported to the U.S. each day, and FDA cannot examine each and every shipment. FDA uses a Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system to determine which imports to examine or sample upon arrival to the United States. PREDICT utilizes data mining, pattern discovery, and open-source intelligence to assess the relative risk of FDA-regulated products. It allows FDA to release low risk and consistently compliant products more quickly and to prioritize higher risk shipments for examination and sampling. In other words, the lower the risk of a product and the better a company’s FDA compliance history, the lower the chance a shipment will get selected for examination and stopped at its port of U.S. entry.
While most shipments are chosen by PREDICT due to a risk-based assessment, the system also uses randomization for an additional level of security. Therefore, even a low-risk or consistently compliant shipment could potentially be stopped for examination or sampling.
Once a shipment is examined or sampled, the Compliance Officer will classify the shipment as one of three things:
- Class 1 – Product will be released
- Class 2 – Results were inconclusive and the shipment will undergo further review
- Class 3 – Product will be detained
If a product is detained and is verified to be in violation of a U.S. law or regulation, the product may be refused. FDA Import Refusals are logged in OASIS, a publically-available database. In some cases where FDA notices a pattern of non-compliance, a company may even be placed on an FDA Import Alert for a certain product. If a company is on an FDA Import Alert, any shipments of that particular product will be subject to detention without physical examination (DWPE) upon arrival to the United States.
During the webinar, FDA offered some tips for handling an FDA examination or detention. Tips included:
- Submit the proper manufacturer information and address
- Submit correct Affirmation of Compliance and hire an experienced Customs Broker
- Study Import Alerts and product requirements, and use a consultant if you’re unsure about anything
- Cooperate with FDA Investigators and submit the information they need as soon as possible
- Wait a couple of days after submission before calling a Compliance Officer, and know your Entry Number (a.k.a., Case Number) when you do
- Use email and a follow-up phone call for lengthy discussions
- Have goods available for FDA appointments
- Be honest with the Compliance Officer about any errors made
- Have all records and documents ready to show if the product is registered and keep all lab analysis results
- Do not release goods until you receive the FDA Notice of “May Proceed”
- Cooperate and comply with time frames and directions from the Compliance Officer
Common mistakes that FDA mentioned included:
- Providing late or incorrect information
- Calling or emailing many FDA offices or staff about one situation
- Falsifying documents
- Ignoring FDA Notices of Actions or Customs and Border Protection Summons and Penalty Notices
- Demanding FDA to release shipments or rescind a refusal
There are many things that can alter a company’s PREDICT score and increase the chance of a shipment being stopped: an invalid registration number, a product or listing number that doesn’t match up with a product code, labeling errors, data from a past FDA facility inspection, a consumer complaint, and others. That’s why it’s important to ensure you understand FDA regulations for your product and are in compliance before shipping to the United States. Registrar Corp helps companies comply with U.S. FDA regulations. We can ensure your company is properly registered with FDA, review your product labels for FDA compliance, and more. Registrar Corp also offers an FDA Compliance Monitor that allows users to monitor FDA compliance issues that may be affecting their PREDICT score.
To learn more about Registrar Corp’s available services, visit www.registrarcorp.com, contact +1-757-224-0177, or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
May 19, 2015 by David Lennarz
Filed under: Food & Beverages |
The United States is the largest candy consuming country in the world. According to the National Confectioners Association, Americans spend over 30 billion dollars on confectionery products each year and annual sales are expected to grow. With all that demand, it’s no wonder that countries around the world export billions of dollars’ worth of confectionery and chocolate products to the U.S. each year. In 2013, the U.S. imported approximately 1.6 billion dollars’ worth of confectionery products and 2.1 billion dollars’ worth of chocolate products, with Canada and Mexico being the largest suppliers.
With holidays like Halloween, Easter, and Valentine’s Day, the U.S. is a great market for candy, but foreign candy manufacturers should be aware of U.S. Food and Drug Administration (FDA) regulations that can prevent candy shipments from reaching the country. For example, FDA has multiple Import Alerts that subject certain candy products to detention without physical examination (DWPE) at ports of U.S. entry. Import Alert 33-10 subjects shipments from red-listed companies to DWPE due to candy contaminated with lead. Import Alert 34-02 subjects shipments from red-listed companies to DWPE due to candy imbedded with non-nutritive objects. According to the alert, FDA does not allow non-nutritive objects to be partially or fully imbedded in confectionary products unless FDA has issued a regulation that exempts the particular object.
Certain Import Alerts pertain to any and all companies shipping candy to the United States. Under Import Alerts 33-04 and 33-15, all shipments of candy pacifiers and gel candies containing Konjac are subject to DWPE because they pose a potential choking hazard. Candy manufacturers can be affected by non-candy-specific Import Alerts as well. Import Alert 45-02, which subjects foods containing illegal or undeclared colors to DWPE, lists plentiful candy manufacturers. Many candy manufacturers can also be found on the red list for Import Alert 99-19, which is for products contaminated with Salmonella.
It’s important to be aware of FDA Import Alerts that may affect your shipments. Registrar Corp’s FDA Compliance Monitor allows users to check whether their own company or their suppliers are subject to an FDA Import Alert. If so, Registrar Corp may be able to help you petition for removal. For assistance with FDA Import Alerts or other FDA regulations for candy manufacturers, contact Registrar Corp at +1-757-224-0177 or Live Help is available 24 hours a day at www.registrarcorp.com/livehelp.
May 14, 2015 by David Lennarz
Filed under: Medical Devices |
Manufacturers of sunlamp products and UV lamps intended for use in sunlamp products that were offered for sale prior to September 2, 2014 are required to submit premarket notification (510(k)) for those products to the U.S. Food and Drug Administration (FDA) by August 26, 2015 if they wish to continue selling them in the United States. Until June 2014, sunlamp products and UV lamps were considered class I medical devices and were exempt from 510(k) submissions. On June 6, 2014, FDA published a final order reclassifying them to class II devices subject to 510(k) submissions. FDA noted that there were approximately 25 firms registered as manufacturers of sunlamp products or UV lamps at the time of the final order publication.
For sunlamp products and UV lamps not offered for sale before September 2, 2014, the 510(k) submission requirement became effective on September 2. This is also true for devices offered for sale prior to September 2 that were required to submit a new 510(k) due to significant changes to the device. FDA’s decision to reclassify sunlamp products and UV lamps stemmed from new information evaluated by the agency which showed that UV radiation is a significant contributing factor in developing skin cancer, and the number of females exposed to indoor UV radiation who are diagnosed with skin cancer is increasing.
Multiple comments in the order expressed concern for 510(k) submissions in varying situations. FDA’s responses indicated that a sunlamp product and its UV lamp can be included in the same 510(k) submission whether the UV lamp is sold separately or not. UV lamp manufacturers do not need to submit a 510(k) for each possible tanning bed or booth for which the lamp may be used, but they must specify the type of sunlamp products with which the lamp is compatible. FDA allows bundled 510(k) submissions for related UV lamps.
Registrar Corp assists medical device companies with U.S. FDA regulation compliance and can review a 510(k). Registrar Corp’s Regulatory Specialists can verify that a 510(k) is properly formatted and contains all necessary elements and information. After reviewing a 510(k), Registrar Corp will submit the 510(k) to FDA, facilitate payment, and correspond with FDA on the company’s behalf. For assistance or questions about FDA regulations for medical device companies, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
May 11, 2015 by David Lennarz
Filed under: Food & Beverages, FSMA |
The U.S. Food and Drug Administration (FDA) is expected to publish final versions of its Foreign Supplier Verification Program (FSVP) and Produce Safety rules by October 31, 2015. These are two of the major proposed rules under the Food Safety Modernization Act (FSMA). FDA published the original proposed Produce Safety rule on January 16, 2013 and the original proposed FSVP rule on July 29, 2013. FDA published revisions to both proposed rules in September 2014.
The Produce Rule will require covered farms to “take appropriate measures to minimize the risk of serious adverse health consequences or death from the use of, or exposure to, covered produce.” This includes, but is not limited to, actions such as following certain hygienic practices, testing and treating agricultural water sources, and identifying potentially contaminated produce and avoiding harvest of that produce. Covered farms will also need to keep records of training, testing results, treatment of seeds and beans, and other activities. Most raw agricultural commodities are covered by the rule.
The FSVP rule will require U.S. importers to “perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of domestic food producers.” Importers will be required to maintain a written hazard analysis that identifies and evaluates potential hazards for each food they import. They will also need to conduct and document risk assessments and supplier verification activities. The FSVP rule applies to most food imported or offered for import into the United States.
When determining appropriate verification activities for a certain supplier, the importer will need to consider the supplier’s FDA compliance history, such as whether the supplier is the subject of an FDA warning letter or Import Alert. Registrar Corp’s FDA Compliance Monitor allows users to monitor the FDA compliance status of any food facility around the world. Along with assisting with future FSVP compliance, the FDA Compliance Monitor helps importers avoid costly delays and detentions by notifying them of Import Alerts in advance of importing.
FDA discussed some of its plans for Produce Safety and FSVP implementation at the FSMA Public Meeting hosted last month. For both rules, FDA is working to ensure that inspections and regulation are consistent and to provide easily accessible training and support for both regulators and industry.
Registrar Corp assists food facilities with FDA compliance. For questions about FSMA rules or other FDA regulations for food and beverages, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
May 8, 2015 by David Lennarz
Filed under: FDA News, Medical Devices |
In 2014, the U.S. Food and Drug Administration (FDA) reviewed 69 percent of medical device product codes subject to post-market approval (PMA) and identified 21 of them as candidates for reclassification from class III (high risk) to class II (moderate risk). One of the agency’s strategic goals for 2014 and 2015 was to “assure the appropriate balance between premarket and postmarket data requirements to facilitate and expedite the development and review of medical devices, in particular high-risk devices of public health importance.” To accomplish this goal, FDA decided to review medical devices subject to PMA to determine whether or not to reclassify or change the premarket requirements for some of the devices.
Originally FDA’s goal was to review 50 percent of product codes subject to PMA in 2014 and the other 50 percent by the end of 2015. The agency may complete their review of the remaining devices earlier than expected, as they surpassed their target for 2014. FDA has not yet indicated what its subsequent regulatory steps will be once its review is complete. Below are the 21 product codes identified as being candidates for reclassification thus far:
- LFD Saliva, artificial
- LLX Catheter, sampling, chorionic villus
- LMF Agent, absorbable hemostatic, collagen based
- LNC Applicator, hyperthermia, superficial, rf/microwave
- LOA Device, testicular hypothermia
- LOB Dilator, cervical, synthetic osmotic
- LOC System, rf/microwave hyperthermia, cancer treatment
- LOF Bone growth stimulator
- LPQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- LTF Stimulator, salivary system
- LZR Ultrasound, cyclodestructive
- MBU Condom, female, single-use
- MRK System, imaging, fluorescence
- MVF System, laser, photodynamic therapy
- MVG System, laser, fiber optic, photodynamic therapy
- MYL Assay, enzyme linked immunosorbent, parvovirus b19 igg
- MYM Assay, enzyme linked immunosorbent, parvovirus b19 igm
- MYN Analyzer, medical image
- NXG Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
- NZC Stent, urethral, prostatic, semi-permanent
- OAY Light source system, diagnostic endoscopic
Devices that are reclassified to class II will no longer be subject to PMA, but may be subject to premarket notification (510(k)). 510(k) submissions allow FDA to determine whether a new device is substantially safe and equivalent to a device already on the market.
Registrar Corp assists medical device companies with U.S. FDA regulations. We can help determine the classification of a device, as well as assist in developing or reviewing a 510(k). For assistance with FDA regulations for medical devices, contact Registrar Corp at +1-757-224-0177 or live help is available 24 hours a day at www.registrarcorp.com/livehelp.
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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