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With approximately 32% of the fresh vegetables, 55% of the fresh fruit, and an overall 15% of the food consumed in the United States being imported from other countries, the Foreign Supplier Verification Program (FSVP) is one of the most important rules established under the Food and Drug Administration’s FSMA. The purpose of the Food Safety Modernization Act (FSMA) is the prevention of food safety hazards throughout the supply chain and to provide the FDA with the resources and authority to take actions necessary for protecting US consumers — regardless of where the food was produced. As part of that mission, the FSVP Rule mandates importers to assure all imported foods meet the same stringent food safety standards as those required for food products produced in the US. Jump to One of These Sections: What is the FSVP Rule Who is Subject to FSVP Compliance The FSVP Checklist for Success Top FSVP Violations in FY2023 FSVP Modified Requirements & FSVP Exemptions Required Documents for FSVP Compliance Is FSVP Certification Required? How to Simplify FSVP Compliance What is the FSVP Rule? FSVP stands for Foreign Supplier Verification Program. With this rule, the US Importer is defined as the entity and/or person responsible for the safety of the food that they are importing. Every importer subject to this rule must implement and maintain FSVPs in which they evaluated and approved each of their food and beverage suppliers. It also mandates that these Importers have conducted supplier verification activities to assure the food is both safe and in compliance with FDA food safety requirements, as applicable. An importer’s FSVP must make sure that: All food is produced in a manner that meets the same level of public health protection as with established preventive controls for human food or animal food, and/or the produce safety rule, as applicable Imported food is not considered adulterated as defined under section 402 (§342) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) Food products intended for human consumption are not misbranded concerning food allergen labeling as defined under section 403(w) of the FD&C Act Who is Subject to FSVP Compliance? Under the Foreign Supplier Verification Program, US importers are required to evaluate and approve suppliers and to conduct supplier verification activities. An importer is defined as the US owner or consignee of the food offered for import at time of entry. This is someone who either: Owns the food Has purchased the food Has agreed in writing to purchase the food at the time of US entry If there isn’t a US owner or consignee at time of entry, the foreign owner must designate a US agent or representative to fulfill FSVP responsibilities. This must be confirmed in a signed statement of consent. An FSVP importer must be located and conduct business in the United States meaning they must have personnel physically present in the United States. Essentially, if there is a written agreement, paid invoice, or a purchase order for food for a specific US entity at the time of US entry, then that US entity meets the definition of owner and is therefore responsible for and subject to FSVP. FDA is not looking at the intermediaries, but at the consignee, owner, or US Agent designated for FSVP purposes. The FSVP Checklist for Success FDA has made FSVP requirements quite clear and for each category of food you import, there must be a written FSVP for each supplier which must be developed and implemented by a Qualified Individual. The FSVP must detail all the necessary verification activities and documentation to demonstrate compliance for each of your suppliers. This includes the creation of documented processes for confirming the compliance of the foreign supplier, maintaining records, and conducting other essential tasks like taking corrective actions when issues are discovered. FSVP requirements are as follows: An FSVP importer must evaluate any food risk by checking each supplier’s food safety history and performing a hazard analysis by reviewing the process for any foreseeable hazards. An FSVP importer must verify each supplier by either an annual on-site audit of each supplier’s facility, sampling and testing, a review of food safety records, or the use of a third party to verify and provide proper documentation. Though the requirements seem straightforward enough, there can be many steps and considerations that can complicate FSVP compliance. We’ve put together a simple checklist of actionable steps that help take the complexity out of the process: 1. Designate your FSVP Qualified Individual The FSVP qualified individual (QI) is a person who has the education, training, or experience necessary to perform FSVP activities and can read and understand the language of records that they must review. It is important to know that in order to conduct supplier evaluations and FSVP activities, the QI must understand the FDA regulations applicable to the food. The QI is not required to be an employee of the importer. 2. Identify Suppliers and Food Products to Be Imported The first step to FSVP compliance is to have a complete list of the food products you import and who the foreign suppliers are for those products. You will also want to take note of which foods are subject to or are exempt from FSVP. This identification is essential for evaluating and approving the correct supplier, identifying the applicable FDA food safety regulations, conducting an adequate hazard analysis, and determining and performing proper verification activities to ensure food safety. What Is A Foreign Supplier Under FSVP? It's the entity that manufactures or processes the food, grows the food or raises the animal. In other words, it's the manufacturer or processor of the food — or the farm in the case of fresh agricultural commodities and live animals for use in food (outside of those regulated by USDA). Some examples FDA gives are boar, elk and bison. 3. Evaluate Supplier’s Compliance According to Regulations You must evaluate the foreign supplier’s FDA compliance history and their food safety practices to determine their adequacy and if corrective actions are needed for approval. This includes evaluating if the supplier has had any import refusals, import alerts, recalls, failed inspections or other FDA actions issued against them. You must also evaluate the food safety related procedures, processes, and practices. Reviewing their food safety plan, procedures for implementing controls measures, sanitation practices, third-party audit reports, etc. are examples of records you may review to reach compliance determinations. It is critical to take corrective actions when issues are discovered. 4. Determine Associated Hazards After evaluating the supplier’s compliance and food safety practices, it's important to assess the risks associated with the products. This encompasses the possible biological, chemical, and physical hazards that are likely to occur in the food, the ingredients, within the production environment, and the packaging. It also encompasses many other factors including everything from farming practices and environmental contaminants to the equipment used and natural disasters, etc. It also considers the supplier’s food safety history in determining the likelihood of a hazard. 5. Identify Your Verification Activities Based on the results of your compliance evaluations and the hazard analysis, you must then identify appropriate supplier verification activities and the frequency that you will conduct them in to assure that the hazards in the food have been controlled and your supplier maintains compliance. This can include, alone or in combination, conducting onsite audits, sampling and testing of the food, and reviewing food safety monitoring records. 6. Monitor & Reevaluate Suppliers Once your FSVP is in place for each foreign supplier, you must continue to monitor and reevaluate the supplier’s compliance over time. Maintaining regular communication with the supplier and closely following their compliance history is key. You’ll want to pay special attention to any import alerts, refusals, or detentions that may arise between them and yourself or other importers. When becoming aware of a compliance concern, you must evaluate if corrective actions are needed and act accordingly. 7. Update & Reassess Your FSVP As you continue to monitor and reevaluate each supplier you may become aware of new information such as changes in your supplier’s food safety plan, product formulation, processing steps, or food safety concerns. You must update and reassess the FSVP as necessary to ensure that your FSVP reflects the changes and the current state of your supplier/product to assure they remain compliant and your assessments and verification activities are still adequate. These changes can affect any and all parts of your FSVP. 8. Maintain all FSVP Documentation & Supplier Records Finally, to demonstrate your continued compliance during an FSVP inspection, it is necessary to maintain both accurate and complete records of all FSVP activities and other pertinent information. The FDA requires you to keep records readily available from the past 2 years. These documents may include supplier agreements, shipping documents, product labels, food safety plans, audit reports, laboratory test results, written assurances, and other documents that you reviewed to determine and verify your supplier’s compliance. All documents must be provided in English during an inspection. Top FSVP Violations in Fiscal Year 2023 Out of over 1700 inspections, 44.2% earned a 483 citation for failure to even develop an FSVP. According to the FDA Data Dashboard for Inspections, 930 FSVP importers were caught without the necessary requirements in place and received either voluntary or official actions indicated, a failure rate of 54%. FSVP Modified Requirements & FSVP Exemptions As with any other regulation, there are certain exemptions and modifications to be considered when determining if or how FSVP affects your business: FSVP Modified Requirements There are various scenarios for which FSVP modified requirements may apply. These may depend on the type of foods offered for import, the country in which the foreign supplier is located, the financial status of the importer and supplier, or even the food’s intended use. For example: If you import dietary supplements, your FSVP must evaluate compliance with Current Good Manufacturing Practices (CGMPs) for dietary supplements as outlined in 21 CFR 111; not the FSMA rules like Preventive Controls or Produce Safety. If you import food from a country under a food safety system recognition agreement (FSSRA) with FDA, you must document that the food is within the scope of the agreement, that it was was processed or grown in that country, and that the supplier is under the oversight of — and in good compliance standing with — that food safety system. If you import food for which hazards are controlled by a food processing facility in the United States, then written assurances for control of those hazards by that food processing facility can satisfy verification requirements. If you are a very small importer or your supplier is a small supplier, then your FSVP verification activities simply consist of obtaining written assurances from the supplier and other basic information. Very small businesses are defined by FDA as having an annual sales and market value of the food they imported, manufactured, processed, packed or held (for example, held for a fee) for the past 3 years — including their subsidiaries and affiliates — that equals an average of less than $1 million for human food, or in the case of animal food, less than $2.5 million. The list above is not all inclusive but gives an idea of different types of modified requirements that the food you import may be subject to. Some FSVP modified requirements make approval and verification simpler, while others may require a more detailed approach and evaluating other food safety regulations applicable to the food. FSVP Exemptions Exemptions under FSVP also apply due to existent regulations, other jurisdictions with oversight on the safety of those products, or due to its intended use or destination, for example: Juice & seafood are subject to FDA’s Hazard Analysis Critical Control Points (HACCP) Meat and poultry are under the purview of USDA regulations at import Alcoholic beverages remain under TTB jurisdiction Foods for research and evaluation purposes only Foods solely for individual use Foods imported for processing and overseas shipment Transshipped foods List of Possible Required Documents for FSVP Compliance Recordkeeping is the most crucial part for demonstrating FSVP compliance. If you do not document your activities and maintain proper records, FDA determines the activities did not happen. Here’s a general list of information that may be requested of you during an FDA inspection in the form of records: Business Details The FDA initiates their inspections with a questionnaire in which they ask general information about your business operations such as: Who the person in charge is Who your FSVP qualified individual for is The list of products you import Your top suppliers and top customers Your financial status and other information However, it is important to know that FDA started their investigation before they contacted you for the FSVP inspection and they already have certain information about your operation. Understanding the details of your operations and having basic information readily available, makes initial interactions smoother and lets FDA know how prepared and aware you are about the business you run. Supplier & Product List The FDA uses Customs’ data in identifying the suppliers and products they want to inspect so they already know who you import from and what you are importing. You do not want to be caught off guard when it comes to this list. You should know with certainty who your active suppliers from the past 2 years are. You will also want to identify who may have been listing you as an FSVP importer without your knowledge or for foods that you don’t import from them. Not knowing this information puts you at substantial risk of receiving citations for suppliers you didn’t even conduct business with. Or, it may reveal suppliers you didn’t know you had and should have had FSVPs for. Product Descriptions & Labels One of the first things you should request from your suppliers is the product descriptions or specifications and their corresponding labels. Keeping this information accurate will not only help you identify the foods you import, but it will also allow you to conduct initial assessments. These assessments include identifying whether FSVP applies to the food in question and which FSVP requirements might apply. You’ll be looking at which food safety regulations you need to verify such as Preventive Controls vs Produce Safety, dietary supplements, low acid canned foods, infant formula, and others. You will also be identifying ingredient related hazards such as unapproved colors and additives and undeclared allergens, and other details that will help you identify controls and verification activities. Purchasing, Shipment, & Receiving Records You are required to verify that the foods you import are from approved suppliers. Purchasing records such as agreements, invoices, and purchase orders indicate products requiring verification of shipment records. This is especially necessary when the food products are received at your facility, a third-party warehouse or another destination you’ve arranged delivery to. This information helps to ensure the imported food is from the supplier you approved and that it is the food you actually purchased. Written FSVP Procedures This includes written steps or SOPs for conducting the various FSVP-related activities such as supplier evaluations and approvals, verification activities, taking corrective actions, managing FDA inspections, listing the FSVP importer at entry, maintaining records, training, among other processes and assigning responsibility for those tasks to a qualified individual. Qualified Individual Qualifications All FSVP activities must be conducted by a qualified individual. The FDA may request the qualifications, evidence of education, training, or experience of personnel responsible for the different tasks required under FSVP. The qualifications required of an individual will vary according to the FSVP requirements that apply to the importer — Standard vs Modified — and the food safety regulations applicable to the food. Verification Activities Importers must perform verification activities to ensure a supplier is compliant at time of approval and that they maintain compliance over time. FSVP verification activities vary according to the requirements the importer and/or supplier and food are subject to. Modified requirements for small businesses require obtaining written assurances as a form of this verification. However, importers subject to the full requirements must conduct more complex activities. All verifications occur at an established frequency and this frequency depends on the individual requirement, the level of risk associated, the type of food or process, how much you import from that supplier, and other factors. These activities also encompass the review of sampling and testing results, food safety records, and onsite audits. When issues are found you must verify that the supplier took corrective actions to resolve those issues. You must then keep evidence that these verification activities were conducted and maintain all the records you reviewed. Reanalysis & FSVP Updates This pertains to all records associated with the revisions made to an FSVP and maintaining the different versions that have been developed over time. Changes to the products imported, supplier food safety procedures, labels, or a supplier’s compliance standing may require a reanalysis of the FSVP. Any modifications made to the FSVP procedures, the FSVP for a supplier such as hazard analysis, verification activities, etc. must be documented and previous versions kept on file for no less than 2 years. Foreign Supplier Compliance Evaluations The evaluations and determinations on foreign supplier compliance must be documented. As the FSVP importer, you must check whether the supplier had warning letters, refusals at the port of entry, import alerts, or other actions regarding food safety violations and determine if corrective actions are needed. This evaluation includes reviewing their general food safety procedures and may even include review of third-party audit reports and/or FDA Inspection reports. You will also need to review the qualifications of the person in charge of food safety or quality control to ensure they are qualified. Some suppliers are hesitant to share their food safety practices, however, you cannot demonstrate compliance without reviewing their procedures, corrective action measures, and their food safety history. Hazard Analysis & Entities Controlling the Hazards If applicable, you must have a written hazard analysis, including the determination of potential food safety hazards and the evaluation of their likelihood and severity. Based on your determinations, you then compare your evaluation with your supplier’s food safety plan or procedures to ensure they’ve addressed the hazards and have appropriate controls in place. You must also identify any hazards that may not be controlled by your supplier and identify the entity responsible for controlling the hazard. A written hazard analysis does not apply an FSVP for dietary supplements. Is FSVP Certification Required? A quick search online will populate thousands of results that speak to FSVP certification courses. These certification courses cover the necessary information for individuals looking to learn how to develop an FSVP on their own. Certification, however, is not required to develop and implement FSVPs for each of your foreign suppliers as you only need a Qualified Individual on staff — or an out-sourced professional — to perform the necessary tasks and to establish each of the components for the FSVP. How to Simplify FSVP Compliance With so much of the US food supply imported from foreign sources, FDA requires exhaustive compliance and verification activities from FSVP importers. Attempting to evaluate your foreign suppliers and the foods you import on your own is certainly an option, though if you’re unfamiliar with the FSVP landscape and the numerous food safety requirements that may apply to the foods you import, it can be a lengthy and difficult endeavor that can eat away at resources better spent elsewhere. You can easily achieve full FSVP compliance by leveraging the world’s largest FDA compliance company in the industry. Registrar Corp has spent the last two decades helping over 30,000 companies each year across 180+ countries navigate the complexities of FDA regulations. We can help you, too. Discover how you can easily manage FSVP compliance 24/7 with Registrar Corp’s industry leading FSVP solutions.

Detention Assistance and Import Alert UpdatesFood & BeverageFSVP

[vc_row][vc_column][vc_column_text]Common U.S. Food and Drug Administration (FDA) violations examples can be found throughout several industries. Though easily avoidable, without the right information on hand, they are just as easy to bring about. Violations can carry with them various consequences and the last thing any business regulated by the FDA wants is to be on the receiving end of a Notice of FDA Action.   Violations can be as simple as pest control and personnel issues or more complex in nature like falling short of FSVP and HACCP. In either case, violations can present major setbacks for a business in the form of detentions, demurrage fees, injunctions, and even criminal prosecution.  The best way to avoid serious consequences to your bottom line is to be aware of these more common FDA violations examples and set systems in place to assure your business doesn’t fall into non-compliance.  What Does FDA Consider a “Violation?”   Any product regulated by FDA that is imported for distribution in the United States must comply with all applicable FDA laws and regulations. This includes the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Food Safety Modernization Act (FSMA), and other related acts that give FDA authority over various industry regulations.   If at any time a business fails to achieve compliance with any of the mandates FDA has set forth, they are in violation and may be subject to various enforcement actions. For example, if a business claims FDA Approval, they may find themselves in violation as the Administration prohibits food and beverage companies from doing so.   The Consequences of These FDA Violations Examples  FDA has jurisdiction over any FDA-regulated food distributed in interstate commerce. This includes imported foods.  There are several actions that can be issued by FDA after an unfavorable inspection. In fact, something as non-compliant product labels can be the cause of several violations.  Here’s a look at some of the compliance actions issued by FDA after an inspection:  FDA Warning Letters   FDA issues warning letters to notify firms of significant regulatory violations and provides an opportunity for the firms to take voluntary corrective actions. A firm must respond to an FDA Warning Letter within 15 business days with a list of corrective actions and any supporting evidence to demonstrate compliance. The FDA will then determine if the actions are appropriate to address the issues raised or if further action is needed.  FDA Warning Letters are made public in FDA’s Data Dashboard. A Warning Letter may remain public even after its status has changed or it has been closed by FDA. Furthermore, FDA Warning Letters are not required prior to FDA issuing enforcement action.  Seizures of Products   Simply put, a product seizure is brought against an FDA-regulated product when it is found to be adulterated or misbranded within the context of the FD&C Act.   Seizures are intended to remove products from the U.S. market and place them under the custody of the courts until the court determines if they are violative as alleged.   This can come as a serious blow to a business’s bottom line as court fees, market delays, and other consequences begin stacking up due to something as simple as a labeling error causing FDA to deem your product misbranded.   Consent Decrees and Injunctions   An injunction can either be permanent or temporary in nature. Injunctions are court orders that require a defendant to either perform an act in which they are already obligated by law, or forbids the defendant from doing a specific act they are attempting to do.   If deemed necessary, FDA will request that the courts grant an injunction to halt or prevent violation of their regulatory mandates. For example, the Administration can set forth an injunction to prevent products from entering the U.S. market and to force correction of the violation in question.  When an injunction is granted, if a defendant fails to obey the terms of the consent decree, FDA may escalate the issue by initiating civil or criminal contempt proceedings or other regulatory actions.  Criminal Prosecution   Worst of all, if a business finds itself in violation and continues to do so after receiving a court ordered injunction due to intentional disregard or simply repeated mistakes in compliance, they will find themselves on the receiving end of criminal prosecution.  If an injunction is not followed, FDA’s Office of Criminal Investigation will examine any violative activities concerning FDA-regulated products. They will arrest those responsible and bring them before the U.S. Department of Justice for prosecution.   This can result in hefty fines, debarment, import bans, and even imprisonment. Not only does this affect business in the United States, but such actions earn public attention and may cause a greater loss of long-term revenue throughout the global market and supply chain.   The 7 Most Common FDA Violations Examples  Not all FDA violations are major actions that have been taken or neglected. Some can be small and easy to miss: the wrong ingredient on a label, too many flies buzzing around production lines, or personnel failing to wash their hands during an inspection.  Regardless of how major the violation, they can all be equally damaging if not taken care of. That’s why it’s best to understand the requirements and what FDA commonly lists as a violation and prepare your business in advance.  Here are the top 7 violations FDA commonly cites:  1. Pest Control  A common issue in the food and beverage industry, pest control violations often arise due to insanitary conditions and insufficient measures to exclude them from the food processing, packing or holding areas.   Whether it’s an excess of flies in summer, or rats and other pests in storage, food safety is impacted by their presence and FDA will consider your business in violation for their presence.   2. Manufacturing Controls Failure to follow standard operating procedures for manufacturing is one of the more common violations, however, most of these violations are negligent, rather than intentional.   The vast majority of violations in this category revolve around Current Good Manufacturing Practice (cGMPs). They can include anything from a lack of fall protection and hazard communication to failure to provide controlled environments for food handling.   3. Hazard Analysis  FDA requires most facilities to identify potential biological, chemical or physical hazards that may occur and to establish preventive controls as applicable for significant hazards.   For example, a facility can identify areas where inadequate cleaning of equipment may cause cross-contamination. Failure to properly identify these hazards and detail appropriate methods to resolve prevent or control the issues will lead to this common violation.  4. Sanitary Operations  Rather than from various industry horror stories that lead to mass recalls or public health alerts, many of these violations arise from all too common and less headline-worthy reasons.    These can include failure to properly monitor the safety of water that comes into contact with food, the condition and cleanliness of food contact surfaces, or even a lack of maintenance in hand washing and toilet areas. 5. FSVP Violations During Foreign Supplier Verification Program (FSVP) inspections, FDA requires food importers to present complete FSVPs that demonstrate a suppliers’ food safety compliance. More often than not, these violations arise due to simply not having an FSVP plan developed which has been the #1 observation sinve FSVP has been enforced.  6. HACCP Plan Implementation Just as with FSVP, a common mistake that leads to this violation is simply not having a HACCP Plan developed or in place by the time an inspection happens. This HACCP Plan requirement applies to seafood and juice processors. Other common inspection violations include failure to adhere to the plan in general. 7. Personnel Personnel violations can hit any industry and doesn’t only affect food safety. Any industry that requires sanitation concerning the production team can earn FDA violation.   Whether it’s the lack of use of personal protective equipment, or simply poor hygiene in the form of handwashing and hair nets, these violations are among the easiest to earn.  How to Avoid These Common FDA Violations Examples   Enforcement Actions for FDA violations can vary in severity, but when a business continues to violate regulatory compliance mandates — no matter how small — greater action will be taken that can critically affect business.   Attempting to navigate FDA regulations on your own is certainly an option, though if you’re unfamiliar with the compliance landscape for your industry it can be a difficult and risky endeavor.  You can easily avoid these damaging violations and achieve full regulatory compliance by leveraging our 20 years of experience in the industry.   Registrar Corp has spent the last two decades helping over 30,000 companies each year across 175+ countries navigate the complexities of FDA compliance. We can help you, too.  Discover how we make FDA compliance quick and easy and avoid the pitfalls of these common FDA violations examples. [/vc_column_text][/vc_column][/vc_row]

Food & BeverageRegistrations and Listings

The Food & Drug Administration (FDA) requires that all food and beverage facilities register and then renew their FDA food facility number biennially. This is to help prevent food supply-related attacks, hazards, threats, and emergencies as mandated by the Bioterrorism Act and the Food Safety Modernization Act (FSMA).  Among other regulations, facilities must register with FDA before shipping to the U.S. to assure compliance, keep their products out of detention, and to avoid demurrage fees. Renewal of an FDA food facility number is required every even-numbered year between October 1 and December 31.  Understanding Food Facility Registration  Your FDA food facility registration number is a critical requirement for your business to market and sell its products in the U.S. The U.S. FDA assigns a unique registration number to each registered food facility to:  Facilitate communication between FDA and a foreign facility for routine and emergency communication   Allow FDA to plan food facility inspections   FFR numbers can also help FDA track your facilities’ activities when investigating the origin of a public safety event. It’s also important to keep in mind that the assignment of the FDA registration number does not imply the approval of your establishment or product by the U.S. FDA. Instead, the FDA registration number only recognizes that your establishment is registered with the U.S. FDA.  Obtaining a Food Facility Registration Number  Regardless of whether your facility is located internationally or in the United States, FDA requires all facilities that manufacture, process, pack, or hold food and beverages for distribution in the United States to both register and renew.   When applying for a food facility registration number there are several pieces of information you should have on hand:  A Unique Facility Identifier number; a 9-digit DUNS number  Facility name & address information  Parent company name & address information if applicable  Facility emergency contact information  Any trade names used  U.S. Agent who has accepted this designation if the facility is internationally located  General product categories and the type of activity conducted at the facility  Information regarding the Owner, Operator, or Agent in Charge  After the U.S. Agent has accepted their designation and once this information is submitted, reviewed, and accepted by FDA, you will then be given an 11-digit food facility registration number and are one step closer to distributing products throughout the United States.   Significance of Food Facility Registration Numbers  Registration of your facility helps provide transparency in the global supply chain. FDA is able to use this number to locate and track the source of any threats to public safety — such as any harmful contamination of the products — to prevent further spread or recurrence of harmful food safety issues.  Obtaining registration also opens the entire U.S. market to your business, allowing your products to reach 160-million consumers with disposable income.  Ignoring registration not only bars your products’ entry to the United States, but any attempt at exporting to the U.S. may land your product in detention or force legal and federal action against your business.   Maintaining Food Facility Registration  It’s important to understand that once registration is accepted by FDA and you have been given your food facility registration number, you will be required to update FDA regarding any changes to your registration and to renew every 2 years.  Updating FDA Registration  A facility’s registration must be updated within 60 calendar days of any changes to the information originally submitted during registration except in the case of ownership changes. Examples of when to update include (but are not limited to):  Relocation of facility  A change of operator  New agent in charge  Change of U.S. Agent  Any changes to your DUNS information  FDA has technically required all Food Facilities to report a DUNS Number since 2020, but did not start enforcing this requirement until March 2023. FDA is now routinely reviewing its records and canceling registrations where the agency finds the DUNS an unacceptable representation of the FFR data.    That means a registration number that was valid last month could be cancelled this month, and you don't want to find that out when you have a shipment on the water. Failure to update in a timely manner may also earn a suspension or even cancelation of your food facility registration number.    Renewing FDA Registration  FDA requires all facility registrations to be renewed every even-numbered year between October 1 and December 31.  Failing to renew will result in FDA treating your registration number as expired and will then cancel your registration. This will immediately place moving shipments — and your bottom line — at risk. Not only can your products be refused entry, they can be seized and placed in detention, accrue demurrage fees, they can be destroyed on site, or simply risk spoilage if held for too long.   Verifying FDA Registration  The FDA may invalidate a facility’s registration for a number of reasons, from lack of current information to missing renewal deadlines. Without a correct and complete registration, your company could face serious fees, fines, or shipment detentions and delays. If you have any question about the status of your registration, you should seek verification.  Registrar Corp offers U.S. FDA registration verification at no cost so that suppliers can quickly determine whether their registrations are valid and in compliance with FDA’s requirements.  How to Simplify FDA Registration  Assuring you have the correct documents on hand for your specific needs and submitting accurate information to FDA can be challenging for many businesses. Staying on top of updates and renewals can pose an equal challenge when business operations, personnel, and pushing the initiatives that matter most demand your attention.  Registrar Corp makes FDA Registration quick and easy.  We’ve spent the last two decades helping over 30,000 companies each year across 175+ countries understand the complexities of U.S. FDA regulations. From food facility registration numbers to meeting all FSVP & FSMA requirements, we know how to help you navigate and achieve compliance.   Register your food facility with FDA the right way. 

DrugsMedical Devices

FDA’s approach to granting marketing approval to the products it regulates varies widely. Each product, and in some cases, product class, has its own FDA approval processes and requirements.   Some products, such as drugs and high-risk medical devices, go through strict testing and reviews before they can be sold in the United States. Others must pass safety requirements for human consumption, performance standards, or closely resemble other products on the current market. Many products don't need any prior approval or clearance.  In this article, you will learn some of the differences between different FDA approval processes and how they apply to different regulated products.  FDA Cleared vs Approved  FDA approves products based on the relative risk they pose to consumers. Both FDA Clearance and FDA Approval indicate that the product is considered safe and effective for distribution on the U.S. market.   The more complex a product is and the higher its potential risk for human or animal use, the more testing and review it requires before approval. Overall, FDA approval has a much stricter set of processes designed to safeguard consumers and determine how safe and effective a product is. FDA experts review products’ safety, quality, and effectiveness before giving approval.   FDA bases clearance status on previous approvals of similar products or devices or gives it to products considered much lower risk. There are also many products that don’t require clearance by FDA.  Even after products are approved or cleared, companies must continue to comply with FDA regulations and take corrective action if safety issues arise.  The processes for “FDA Cleared” and “FDA Approved” status vary based on the type of product and how it’s classified. FDA Approval status specifically refers to certain types of drugs and medical devices, with a few exceptions. Only lower-risk medical devices (Class I and Class II) are cleared by FDA, if they are not considered exempt by the Federal Food, Drug, and Cosmetic Act (FD&C Act).  What Does FDA Approve?  Here are some examples of healthcare products that FDA has to approve before they are sold on the U.S. market:  New drugs: Drugs new to the market that may contain new chemical formulas or established formulas prescribed for different uses that have not been declared safe and effective  Human biologics: Biological products such as proteins, vaccines, and allergenic products, human cells, tissues, and cell and tissue-based products (HCT/Ps)  Highest-risk medical devices: Complex devices that are of very high risk to users, such as pacemakers and defibrillators  Food and color additives: Natural and synthetic substances added to food, drugs, cosmetics, and medical devices that can be harmful to humans   FDA does not currently approve:  Food or beverages  Facilities, providers, or laboratories  Compounded drugs  Cosmetics  Medical foods or dietary supplements  To learn more about products that FDA approves across the industries it regulates, read our guide to FDA approval.  FDA recommends companies become familiar with the guidances and develop a transition plan that addresses the steps that must be taken if they wish to continue marketing their devices in the U.S.   Gain and maintain FDA compliance. At Registrar Corp, we’re committed to helping medical device companies comply with FDA regulations. To learn more about how our team can help, call, email, or reach out to a Regulatory Specialist 24/7.  Learn More FDA Approval for Drugs   FDA approves newly developed and prescribed brand name and generic drugs through the Center for Drug Evaluation and Research (CDER). Drug companies send CDER data from multiple clinical trials to prove the product is safe and effective for its intended use. FDA experts then closely review data along with the drug’s proposed labeling.   FDA approves the drugs by analyzing factors such as:  Target condition and treatments: Reviewers analyze the illness or condition the new drug aims to treat as well as current treatment options on the market. This helps them weigh the risks and benefits of consumer use.  Clinical data: FDA checks drug companies’ clinical data to determine how safe it is for human use, assesses clinical benefits and risks, and compares data from trials to verify results. In some cases, companies may only have to submit data from one clinical trial, especially if the disease is rare.  Risk management strategies: Reviewers determine how drug companies can best communicate known and potential risks of the drug once it’s on the market. This may include labeling that clearly states risks and information on detecting and managing risks or creating and implementing a Risk Evaluation and Mitigation Strategy (REMS).  A drug has to have enough benefits to outweigh known or potential risks for its target patients to get FDA approval. FDA Approval for Medical Devices  Medical devices fall into three categories:  Class I: Devices that are considered low risk for human use and have the lowest potential for harm, such as tongue depressors, toothbrushes, and bandages. They make up the largest portion of all medical devices.  Class II: Devices considered to be of moderate to high risk to humans, including pregnancy test kits, syringes, and powered wheelchairs.   Class III: Devices that present high potential risk or harm to users, such as breast implants, pacemakers, and defibrillators. They make up the smallest portion of all medical devices, around 10%.  FDA requires a premarket approval (PMA) application for Class III devices, which are designed to support or sustain human life and represent the most potential risk. PMA is FDA’s most rigorous regulatory requirement.  To gain PMA, manufacturers of Class III devices must provide sufficient scientific evidence that their products are safe and effective. Applicants must receive FDA approval for their PMA application before marketing and distributing their device. Without approval, the Class III device would be considered unsafe for human use and cannot be marketed.   FDA Clearance for Medical Devices  FDA clears some types of lower-risk (Class I and Class II) medical devices, a form of marketing approval also known as a 510(k). However, most Class I devices don’t require clearance by FDA.  510(k) is a premarket notification that medical device companies submit to FDA which demonstrates that their device is substantially equivalent to another device on the market that has already been determined safe and effective for consumer use. In other words, it must be substantially equivalent to a device that doesn’t require premarket approval.  While most Class I devices are exempt from 510(k) clearance, most devices that need premarket notification are in Class II and must follow performance standards or Special Controls.  FDA considers a majority of Class I and some Class II devices exempt from 510(k) clearance. These include:  General Biological Products  Diagnostic substances for laboratory tests  Clinical chemistry and toxicology devices  Hematology and pathology devices  Immunology and microbiology devices  Anesthesiology devices  Cardiovascular devices  Dental devices  Ear, nose, and throat devices  Gastroenterology-urology devices  General and plastic surgery devices  General hospital and personal use devices  Neurological devices  Obstetrical and gynecological devices  Ophthalmic devices  Orthopedic devices  Physical medicine devices  Radiology devices  Premarket notification must be submitted at least 90 days before you introduce any device into interstate commerce for commercial distribution.  Keep Up FDA Compliance with Registrar Corp  Registrar is a global leader in regulatory compliance for drugs, medical devices, and other FDA-regulated industries. We offer a wide range of compliance and support services for drug and medical device companies, including FDA registration and listing.  Every year, we work with over 30,000 companies on FDA registrations and renewals and help our clients comply with a variety of FDA regulations.  Our FDA registration service includes:   FDA Registration and Renewal assistance  DUNS number assistance  Detention assistance  Prior Notice filing  Mock FDA Inspections (for an additional reduced fee)  Learn more about our FDA registration services today.    More About How FDA Approves  Not ready to register yet? Keep reading about FDA approval and how it works for regulated industries.  How To Get FDA Approval  Medical Devices 101: Controls and Classifications  FDA Regulations for OTC Human Drugs 


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