On June 2, 2017, the U.S. Food and Drug Administration issued a letter announcing that the Agency intends to extend the Unique Device Identification (UDI) compliance dates for class I and unclassified devices (excluding implantable, life-supporting or life-sustaining devices) to September 24, 2020 (two years after the original compliance date). FDA plans to solidify this extension with a guidance document regarding its enforcement discretion, but the Agency wanted to inform industry of its decision as early as possible.
Device labelers are responsible for implementing FDA’s UDI requirements. According to the letter, many labelers asked FDA for an extension upon realizing the substantial amount of time the process takes. The letter also notes that “providing accurate and timely support to labelers has also been challenging, due to the sheer number and wide diversity of devices,” which leads us to believe many labelers are having difficulty completing the process on their own.
With this in mind, it’s prudent for device labelers to begin preparing for the 2020 UDI compliance date as early as possible to ensure they meet the requirements on time. Registrar Corp’s Regulatory Specialists can help you navigate the UDI process, including obtaining a DUNS number, calculating how many UDIs you will need, and more. For assistance, simply complete the form below:
Many U.S. importers are required to comply with the U.S. Food and Drug Administration (FDA) Foreign Supplier Verification Program (FSVP) rule by May 30, 2017.
Finalized in November 2015 under the Food Safety Modernization Act (FSMA), FDA’s FSVP rule requires “FSVP Importers” to perform certain activities to verify that the food they import is produced in a manner that meets U.S. safety standards. If you are unsure whether you are considered an FSVP Importer, Registrar Corp’s free FSMA Wizard can assist you in determining your potential requirements.
Evaluating and Approving Suppliers
FDA’s FSVP rule requires that FSVP Importers import only from approved foreign suppliers, although they may import from an unapproved supplier on a temporary basis. To approve a supplier, an FSVP Importer must consider the supplier’s compliance with FDA food safety regulations, including whether the supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety.
Comments in the final rule regarding this requirement reflect industry concern that FDA’s website and compliance databases can be hard to navigate. To evaluate a supplier’s compliance using FDA’s website, an FSVP Importer has to search each of FDA’s applicable databases for each individual supplier. Registrar Corp’s FDA Compliance Monitor allows users to easily evaluate food facilities’ FDA compliance statuses. The Monitor compiles data on FDA Import Alerts, Warning Letters, Import Refusals, and Inspection Classifications for a user’s suppliers in a simple dashboard, which also tracks whether suppliers are approved.
FSVPs must be created by a “Qualified Individual,” defined as an individual with the education, training, or experience necessary to perform their assigned activities and the ability to read and understand the language of any records that must be reviewed in performing an activity. An FSVP must include a hazard analysis and appropriate supplier verification activities to provide assurance that these hazards will be significantly minimized or prevented. Examples of supplier verification activities include audits, records review, and sampling and testing.
What qualify as “appropriate” verification activities for a particular supplier depends on the types of foods being imported and the supplier’s compliance history. Registrar Corp’s Food Safety Specialists act as Qualified Individuals and can develop or review FSVPs to ensure they are appropriate for your specific needs.
Should an FSVP Importer become aware of non-compliance by one of its approved suppliers, the importer must ensure corrective action is taken. Registrar Corp can assist in implementing corrective actions. For example, action taken to have a foreign supplier removed from import alert may be considered an appropriate corrective action. Registrar Corp can help facilities create and submit a petition to FDA for removal from import alert. Additionally, labeling errors are one of the largest causes for warning letters and detentions. Registrar Corp can review food labeling and ingredients for FDA compliance.
For more information, attend Registrar Corp’s free FSVP webinar or utilize their 24-hour online Live Help.
This article was originally published as a press release.
There were 149,933 food facilities registered with the U.S. Food and Drug Administration (FDA) as of February 2, 2017. Of those registered facilities, 70,976 (47%) were outside of the United States. See the number of registrations by country here.
The ten countries with the largest number of FDA registered food facilities remain the same in 2017 as those reported in 2016:
United States (78957)
Republic of Korea (2393)
Earlier research revealed there were 207,653 food facilities registered with FDA on January 1, 2016, meaning there was a 28% decrease in the number of registered facilities between then and February 2017. This steep drop in registered facilities is likely due to FDA removing food facility registrations that were not properly renewed by December 31, 2016 from its registration database
This drop in registered facilities is greater than the 14% drop that occurred after the 2014 renewal period. This is likely due to new verification requirements implemented during the 2016 renewal period. Food facilities located outside of the United States are required to designate a U.S. Agent for FDA Communications in their registration renewal. Unlike in previous years, individuals or entities listed as U.S. Agents in 2016 were required to confirm with FDA acceptance of their designation and corresponding responsibility. FDA did not consider a facility’s 2016 renewal confirmed unless the designated U.S. Agent affirmatively agreed in writing. If a foreign facility submitted its registration renewal but its U.S. Agent did not affirmatively agree, its registration was removed from FDA’s food facility registration database.
Manufacturing, processing, packing, or storing food for US consumption without a valid FDA registration is a prohibited act. Many facilities do not realize that FDA removed their registrations until problems occur. To avoid costly detentions or regulatory action, it’s prudent for all food facilities to verify that their FDA registrations were properly renewed for 2017 before continuing with business as usual. This is especially true for food facilities located outside the U.S. Registrar Corp will verify that your FDA food facility registration was properly renewed at no cost. Facilities that need a U.S. Agent may retain Registrar Corp. Simply contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
This article was originally published as a press release
The U.S. Food and Drug Administration (FDA) recently removed from its database of active registrations all medical device establishments that did not register for 2017. Owners or operators of device establishments must register annually with FDA. In early February, the Agency warned industry that it would remove all establishments that had not registered for 2017 by February 23.
Devices manufactured, prepared, propagated, compounded, or processed in an unregistered establishment are misbranded and thus subject to regulatory action if sold in the United States. Registrar Corp is urging medical device companies to confirm their establishments are listed in FDA’s database as registered for 2017 before continuing business as usual: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
The registration fee for fiscal year (FY) 2017 is $3,382. Registrar Corp can help medical device establishments verify that their registrations were completed for 2017 as well as register device establishments with FDA and facilitate payment of the associated fees. For assistance, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
On February 14, Registrar Corp, a U.S. Food and Drug Administration (FDA) consulting firm, launched two free tools to assist food facilities in complying with FDA requirements for Low-Acid Canned and Acidified Foods.
Most facilities that manufacture, process, pack, or store food intended for consumption in the United States are required to register with U.S. FDA as food facilities. Food facilities that produce certain shelf-stable, hermetically-sealed low-acid canned or acidified foods must also obtain a Food Canning Establishment (FCE) registration. FDA requires FCE manufacturers to file documentation for each process used in the production of Low-Acid Canned and Acidified Foods and assigns unique “Submission Identifiers” (SIDs) to each of these “Process Filings.” Common examples of foods subject to FDA’s FCE and SID requirements include canned tuna, canned roasted red peppers, and coconut water.
Registrar Corp’s FCE Wizard allows users to identify whether their products are subject to these FDA FCE and SID regulations. Users simply answer a few questions, and the FCE Wizard generates a free report indicating possible requirements for each of the facility’s products based on factors such as pH, water activity, and ingredients.
For individuals aware that their products are subject to FCE-SID requirements but uncertain if a particular SID remains valid, Registrar Corp has developed the SID Verifier. Registrar Corp’s SID Verifier allows users to verify whether SIDs are currently on file in FDA’s database. Manufacturers, importers, and customs brokers filing entries of Low-Acid Canned and Acidified Foods will find this tool especially helpful, as valid SIDs must be submitted as “Affirmation of Compliance Codes” (AofC) when importing these products into the United States. Verifying SIDs before filing can help avoid time-consuming detentions and entry errors that may lead to low filer evaluations.
Registrar Corp’s team of FCE specialists provides assistance with the FCE registration process and offers guidance as to required elements, formats, and particularities of SID submissions. For further assistance with FDA FCE and SID requirements, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
To use Registrar Corp’s FCE Wizard, click here.
To use Registrar Corp’s SID Verifier, click here.
This blog was originally published as a press release.
On February 7, the U.S. Food and Drug Administration (FDA) e-mailed medical device establishments that did not complete their annual registration for 2017. According to the e-mail, establishments that do not register and pay the associated fees by February 23, 2017 will have their registration removed from FDA’s database of active registrations. Medical devices manufactured, prepared, propagated, compounded, or processed in an unregistered establishment are misbranded and thus subject to regulatory action if sold in the United States.
The registration fee for the fiscal year (FY) 2017 is $3,382. Registrar Corp can help medical device establishments register with FDA and facilitate payment of the associated fees. For assistance, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
On February 1, 2017, the U.S. Food and Drug Administration (FDA) removed all food facility registrations that were not properly renewed for 2017 from its registration database. Under the Food Safety Modernization Act (FSMA), food facilities are required to renew their FDA registrations between October 1 and December 31 of each even-numbered year. FDA considers any registrations not renewed by the deadline to be expired and removes these registrations from its database. Once removed, registration numbers typically cannot be reinstated. Facilities with expired registrations will need to re-register with FDA and obtain a new registration number before they manufacture, process, pack, or store food, beverages, or dietary supplements to be consumed in the United States.
14% of food facilities registered with FDA were removed from FDA’s database after the 2014 renewal period. Registrar Corp Vice President David Lennarz predicts that the drop in registrations may be even greater this year due to new verification requirements implemented during the 2016 renewal period. Food facilities located outside of the United States are required to designate a U.S. Agent for FDA Communications in their registration renewal. Unlike in previous years, individuals or entities listed as U.S. Agents in 2016 were required confirm with FDA acceptance of their designation and corresponding responsibility.
Prior to this new verification step, a U.S. Agent could be designated in a foreign facility’s renewal without the U.S. Agent’s affirmative written agreement. Many persons previously designated as U.S. Agents would have preferred to decline because a foreign facility’s U.S. Agent is liable for financial obligations, including payment of any FDA re-inspection fees related to the facility. The re-inspection fee rate for foreign facilities for Fiscal Year 2017 is $285 per hour (81 FR 50525). FDA may bill for every aspect of a re-inspection, including time spent preparing and traveling, so the fees can quickly add up to thousands of dollars. FDA also contacts U.S. Agents regarding shipments, inspection scheduling, and other regulatory matters. These matters often require an immediate response.
In 2016, FDA addressed the issue by implementing the new verification procedures. The agency does not consider a facility’s 2016 renewal confirmed unless the designated U.S. Agent affirmatively agreed in writing. If a foreign facility submitted its registration renewal but its U.S. Agent did not affirmatively agree, its registration will have been removed from FDA’s food facility registration database.
To avoid costly detentions or regulatory action, it’s prudent for all food facilities to verify that their FDA registrations were properly renewed for 2017 before continuing with business as usual. This is especially true for food facilities located outside the U.S. Registrar Corp will verify that your FDA food facility registration was properly renewed for 2017 at no cost. Facilities that need a U.S. Agent may retain Registrar Corp. Simply contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
This blog was originally published as a press release.
The U.S. Food and Drug Administration (FDA) recently issued guidance for industry to assist with the submission of warning plans for cigars. On May 10, 2016, FDA published a final rule that granted the agency authority to regulate all tobacco products, including cigars, e-cigarettes, hookah tobacco, and pipe tobacco.
What is a warning plan?
A warning plan details how a company plans to achieve random distribution of the required warning statements on cigar packages and advertisements. For each brand of a cigar product, FDA requires that all statements be displayed on packaging an equal number of times within a 12-month period. All statements must be randomly distributed in all areas that the product is marketed in the US. For advertising, all warning statements must rotate quarterly in an alternating sequence. There are six required warning statements:
- WARNING: This product contains nicotine. Nicotine is an addictive chemical.
- WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
- WARNING: Cigar smoking can cause lung cancer and heart disease.
- WARNING: Cigars are not a safe alternative to cigarettes.
- WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
- There are two options for the reproductive health warning: 1) WARNING: Cigar use while pregnant can harm you and your baby, or 2) SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight
Who submits the cigar warning plans?
A cigar product manufacturer, distributor, importer, or retailer should submit the warning plan. In most circumstances, FDA believes that manufacturers are most capable of creating a sufficient warning plan for packaging.
What is the compliance deadline?
Warning plans for cigars should be submitted to FDA by May 10, 2017 or 12 months before advertising and marketing begin, whichever date is later. FDA expects that a large volume of plans will be submitted near this deadline and thus suggests they be submitted as soon as possible to ensure they are reviewed in time to comply with the warning requirements that take effect on May 10, 2018. FDA has deemed it unlawful for cigar products to be produced, manufactured, or distributed in the United States without the packaging containing one of the required statements once the warning requirements take effect.
FDA encourages cigar product manufacturers, distributors, importers, and retailers to submit warning plans electronically, with all content in Portable Document Format (PDF) format. Electronic submissions must be submitted through FDA’s Electronic Submissions Gateway.
Registrar Corp is a U.S. FDA consulting firm that helps companies comply with FDA regulations. Registrar Corp can help tobacco product manufacturers determine how FDA’s guidance apply to their particular products. Additionally, Registrar Corp can also review tobacco product labels and advertisements to ensure compliance with FDA labeling regulations. For more information, contact Registrar Corp at
+1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp
The U.S. Food and Drug Administration (FDA) recently issued a guidance that extends the compliance dates for tobacco ingredient submissions for newly deemed tobacco products introduced into interstate commerce on or before August 8, 2016. FDA plans to enforce the ingredient list submission requirement on August 8, 2017 for businesses that are not small-scale manufacturers, and on February 8, 2018 for small-scale manufacturers. The original date for compliance was February 8, 2017.
The compliance deadlines have been extended to allow manufacturers and importers additional time to prepare quality submissions. The extension also allows some manufacturers to submit multiple lists for multiple tobacco products.
Ingredient submissions should include the following information:
- Manufacturer/Importer Identification
- Product Identification
- Ingredient Identification
- Ingredient Quality
Registrar Corp assists tobacco manufacturers with FDA compliance, including registration, listing, and labeling requirements. For more information on FDA regulations for tobacco manufacturers, including the recently finalized refuse to accept tobacco rule, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
On December 29, 2016, the U.S. Food and Drug Administration (FDA) published a final rule (81 FR 95863) describing the circumstances under which the agency will refuse to accept a tobacco product submission. Covered submissions include:
- Premarket tobacco product applications (PMTAs)
- Modified risk tobacco product applications (MRTPAs)
- Substantial equivalence (SE) applications
- Exemption requests
According to the rule, FDA will refuse to accept submissions that:
- Are not in English
- Do not pertain to a tobacco product
- Do not identify the tobacco product or the type of submission
- Are submitted in an electronic format that cannot be processed, read, reviewed, or archived
- Do not include the applicant’s contact information (or for foreign applicants, the U.S. Agent’s contact information)
- Do not include the required forms
- Do not include the signature of a responsible official authorized to represent the applicant
- Do not include an environmental assessment or claim of a categorical exclusion, if applicable
Submissions that meet these circumstances will be refused before they enter FDA’s review queue. FDA will inform the listed contact as to whether or not the submission was accepted. FDA expects this rule to accelerate the review process for submissions that meet all requirements by freeing the agency’s review resources.
This rule applies to covered submissions for all tobacco products. Until last year, FDA’s authority over tobacco products was limited to cigarettes and cigarette, roll-your-own, and smokeless tobacco. In May 2016, FDA finalized a rule that extended the agency’s authority to all tobacco products, including (but not limited to) e-cigarettes, cigars, hookah tobacco, and pipe tobacco (81 FR 28973). The rule became effective in August 2016 and requires tobacco manufacturers to submit new products to FDA for premarket review.
Registrar Corp assists tobacco manufacturers with FDA compliance, including registration, listing, and labeling requirements. For more information on FDA regulations for tobacco manufacturers, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.