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FDA to Remove Unregistered Medical Device Establishments from its Database

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.

Registrar Corp Reports: FDA Medical Device Registration Renewals (February 2017)

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.

FDA Removes Thousands of Expired Food Facility Registrations from its Database

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.

FDA Issues Guidance for Submission of Warning Plans for Cigars

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:

  1. WARNING: This product contains nicotine. Nicotine is an addictive chemical.
  2. WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
  3. WARNING: Cigar smoking can cause lung cancer and heart disease.
  4. WARNING: Cigars are not a safe alternative to cigarettes.
  5. WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
  6. 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

FDA Extends Compliance Date for Tobacco Ingredient Submissions

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.

 

 

FDA Finalizes Refuse to Accept Rule for Tobacco Submissions

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.

FDA Establishes User Fees for Accredited Third-Party Certification Program

On December 14, 2016, the U.S. Food and Drug Administration (FDA) published a final rule (81 FR 90186) that establishes user fees for the agency’s accredited third-party certification rule. Finalized in November 2015 as part of the Food Safety Modernization Act (FSMA), the rule establishes a voluntary program for certification bodies to audit foreign food facilities and provide certification when their food safety controls are up to U.S. standards.

There are essentially three steps to the accredited third-party certification program:

  1. FDA recognizes accreditation bodies.
  2. Recognized accreditation bodies accredit qualified third-party certification bodies.
  3. Accredited certification bodies audit and issue certifications for foreign food facilities and their products.

For more information on the program requirements and use of certifications, read here.

FDA’s final rule establishes two types of user fees: application and annual.

Application Fees

Application fees apply to accreditation bodies applying for FDA recognition, recognized accreditation bodies applying for renewal, and to third-party certification bodies applying for direct accreditation from FDA or a renewal of their direct accreditation. The application fees are intended to cover the costs of FDA’s review and evaluation of initial and renewal applications.  These fees must be submitted concurrently with an application and are non-refundable.  Applications will be considered incomplete until payment is made.

Annual Fees

Annual fees apply to recognized accreditation bodies.  The annual fees also apply to accredited certification bodies, whether they were accredited directly through FDA or through an accreditation body. Annual fees are intended to cover the costs of FDA’s performance monitoring efforts. Annual fees must be paid within 30 days of receiving billing.  Failure to pay FDA’s user fees may result in suspension or revocation of a participant’s recognition or accreditation.

The application fee for accreditation bodies applying for initial recognition in fiscal year (FY) 2017 will be $35,100 (81 FR 90363). This cost is slightly lower than the application fee estimated in the 2015 proposed rule.  In the future, FDA will announce the fee schedule prior to the beginning of each FY.

Circumstances under which accredited third-party audits are required are likely to be rare. These audits are only required when a facility’s product is being imported to the US as a VQIP food and in the event that FDA issues a requirement for certification of a specific food due to safety concerns. In the case that your facility does require a third party audit, Registrar Corp offers a mock inspection service to help prepare. Registrar Corp’s Food Safety Specialists will inspect all aspects of your facility, from employee hygiene to equipment maintenance to recordkeeping. Our mock inspection service is also beneficial in preparing for a routine FDA inspection.

For questions regarding FDA’s accredited third-party certification program or other final FSMA rules, contact Registrar Corp by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

 

A Year in Review: FDA Drug and Device Regulations in 2016

Registrar Corp keeps industry up-to-date on regulations throughout the year. In 2016, the U.S. Food and Drug Administration (FDA) proposed several new regulations, including label submission requirements for certain devices, and issued extensions for compliance deadlines.

Here’s a compilation of the happenings for the drug and device industries in 2016.

  • February 18: FDA removed 771 drug facilities from the registration database due to failure to complete their annual registration renewal for 2016.
  • August 1: FDA published its annual user fees for medical devices and generic drugs for fiscal year 2017 (October 1, 2016 through September 30, 2017).
  • September 8: FDA issued a UDI compliance extension for certain Class II devices.
  • September 24, 2016: This marked the Unique Device Identifier (UDI) compliance date for Class II devices. Read here for tips on UDI compliance.
  • October 20: FDA proposed to require label submissions for Class II and Class III home-use devices.
  • December 21: FDA banned the use of powdered medical gloves due to the substantial risk of illness or injury to both patients and medical professionals.

In addition to the various FDA extensions, proposals, and final rules that were released over the last year, the Federal Trade Commission (FTC) issued new labeling disclaimers for homeopathic drugs.

Registrar Corp is looking forward to the new year and continuing developments in FDA regulation of the drug and device industries. For any questions about FDA drug and device regulations, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

 

2016 Round Up – U.S. FDA Food Regulations

2016 proved to be a landmark year for the U.S. Food and Drug Administration (FDA).  The agency wrapped up the finalization of major rules under the Food Safety Modernization Act (FSMA), as well as finalized long-awaited rules that mandate a complete overhaul of food and beverage labeling.  This article presents an overview of the past year in FDA regulations for food and beverage companies.

FDA Finalized the Sanitary Transportation Rule under FSMA

In April, FDA published its final rule for Sanitary Transportation of Human and Animal Food.  The Sanitary Transportation Rule was the sixth major rule to be finalized under FSMA.  The rule created requirements for shippers, loaders, carriers, and receivers of human and animal food transported by motor or rail vehicle within the United States to use sanitary practices to prevent contamination of food during transportation. Most covered businesses are required to comply by April 6, 2017.   Read here to learn about specific requirements of FDA’s Sanitary Transportation rule.

Canada’s Food Safety Systems were Recognized as Comparable to the US

In May, FDA, the Canadian Food Inspection Agency, and the Department of Health Canada signed a Food Safety Systems Recognition Arrangement.  Canada’s food safety systems are now recognized as providing public health protection comparable to those of the United States.  This means that facilities exporting from Canada and importers importing from Canada benefit from certain modifications and exemptions under FSMA.  For example, importers are exempt from the FSVP requirements of conducting a hazard analysis, approving and verifying suppliers, and conducting FSVP activities for their Canadian suppliers, so long as those suppliers are in good compliance standing with their country.

FDA Finalized Changes to Food Labeling

On May 20, FDA finalized two rules that mandate significant changes to labeling of food and beverages.  Changes range from cosmetic (i.e., a larger font size for calories and serving sizes) to new additions (i.e., adding a line for added sugars and adding vitamin D and potassium as listed nutrients) to data-driven (i.e., new daily value calculations for sodium, dietary fiber, and vitamin D).  Most facilities must comply by July 26, 2018.

FDA Finalized the Intentional Adulteration Rule under FSMA

On May 27, FDA published its final rule for “Mitigation Strategies To Protect Food Against Intentional Adulteration,” the last of the seven major FSMA rules.  FDA’s Intentional Adulteration rule requires facilities registered with FDA to develop and implement a written Food Defense Plan for human foods manufactured, processed, packed, or held at the facility.  A facility’s Food Defense Plan must include a vulnerability assessment, mitigation strategies for each identified vulnerability, and a plan to continuously ensure proper and effective implementation of those strategies.  Most facilities are required to comply by May 2019.  Read here to learn more.

FDA Finalized Amendments to Food Facility Registration

In July, FDA published a final rule in an effort to improve the accuracy of the agency’s registration database.  The rule, titled “Amendments to Registration of Food Facilities”, made numerous changes to FDA’s registration requirements and codified some rules that were implemented upon the enactment of FSMA (i.e., registration renewal requirements and inspection permissions).  Some amendments were immediate, such as updates to product and activity categories. Others do not take effect until 2020.  In January 2020, FDA will require food facilities to submit their registrations electronically, and in October 2020, FDA will require facilities to list Unique Facility Identifiers (UFI) in their registrations.  Read here to learn more.

FDA Opened Up The Term “Healthy” For Discussion

In September, FDA published a request for information regarding the term “healthy”.   The decision was sparked by the agency’s desire to reflect current nutrition science as well as petitioning by industry.  FDA is accepting comments through January 26, 2017.  Until the agency lands on a new definition, it is using enforcement discretion to allow manufacturers to use the term “healthy” to describe products that:

  • Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or
  • Contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

These are but some highlights in a busy year for FDA food industry regulators.  Registrar Corp will continue to work to keep industry updated through 2017.  For assistance with U.S. FDA regulations, contact Registrar Corp by phone 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 an article in Food Online.

FDA Bans Powdered Medical Gloves

On December 19, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule (21 CFR Parts 878, 880, and 895) banning powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves. According to the rule, FDA banned these products due to the fact that they present a substantial risk of illness or injury that cannot be corrected by eliminating or altering product labeling.  Adverse events related to powdered gloves include:

  • Severe airway inflammation
  • Hypersensitivity reactions
  • Allergic reactions
  • Lung inflammation
  • Damage to post-surgical adhesions
  • Respiratory allergic reactions

The final rule becomes effective on January 19, 2017. The ban applies to all powdered gloves currently in commercial distribution, those already sold to consumers, and gloves intended to be distributed in the future. All banned gloves must be removed from the market by the effective date.

FDA defines a medical device ban as “a total prohibition on the current and future sales, distribution, and manufacturing of a medical device.” (21 USC 360f) FDA may analyze a device’s risks and benefits in many ways, including, but not limited to, evaluating medical literature, meeting with experts, or comparing the device to its alternatives. Only one other medical device has been banned by FDA since June 1983.

Registrar Corp is an FDA consulting firm that assists medical device companies with FDA regulations. Registrar Corp can help companies determine whether or not their products are banned under this final rule and review product claims for FDA compliance.  For assistance with FDA regulations for medical gloves or other devices, contact Registrar Corp at +1-757-224-0177 or through our 24-hour Live Help chat service: http://www.registrarcorp.com/livehelp

ACE Has Reduced FDA Review Times at the Ports Dramatically

On November 29, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule that establishes requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) system and other authorized systems.

FDA, along with 46 other government agencies, is implementing ACE in collaboration with U.S. Customs and Border Protection (CBP). Some requirements established in the rule include:

  • Clarification that FDA may reject an import filing for failure to provide required data elements
  • Clarification that written notice can be provided electronically by FDA to owners or consignees of FDA actions to refuse and/or subject certain products to administrative destruction
  • FDA is now allowed to provide notice of sampling directly to an owner or consignee

ACE is a “commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, and foster U.S. economic security through lawful international trade and policy.” ACE replaces the Automated Commercial System (ACS), the current commercial database used to submit data through CPB to FDA. FDA plans for ACE to be fully functional by December 29, 2016.

There are several benefits to ACE. FDA reports in the final rule that ACE has dramatically reduced the inspection and review times at U.S. ports for customs brokers and importers registered with the ACE system. The average processing time for manual review of ACS-submitted entries was about 28 hours in 2015, and that has been reduced to less than 2 hours in ACE.  The automated “May Proceed” determination has been reduced from approximately 7.1 minutes in ACS to approximately 2 minutes in ACE.  According to John Verbeten, Acting Director of Import Operations, “since July 23 when ACE became required for all FDA entries, ‘May Proceed’ determinations are now issued for 72% of entries, up from 50% before ACE.” ACE also provides cost savings to both the industry and FDA.

In June 2016, Registrar Corp published this blog to help importers and brokers avoid common errors made when filing in ACE.  Brokers and importers may receive further assistance with ACE filings by e-mailing FDA at [email protected].

For more information on regulations for importing FDA-regulated products to the United States or how Registrar Corp can assist, contact us at
+1-757-224-0177.  Live help is available 24-hours a day at www.registrarcorp.com/livehelp.

 





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