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Food & Beverage

Established as a framework for food producers and manufacturers, the Food Safety Modernization Act (FSMA) serves to prevent contamination of raw materials during processing and in the finished product. Whether you are a farmer, manufacturer, a supplier, or sit somewhere else in the food supply chain, it’s critical to understand what you need to do to maintain FSMA compliance. One of the principal challenges companies encounter when diving into FSMA regulation is understanding the law and the rules and programs it sets forth. Identifying where each rule fits, and how they apply to food facilities and operations can be overwhelming at first. We understand how frustrating navigating the complexities of the regulatory landscape can be. That’s why we’ve made this guide to help you master FDA compliance. Jump to the FSMA Rule that interests you most: Preventive Controls for Human & Animal Food Food Traceability Intentional Adulteration Sanitary Transportation Produce Safety Accredited Third-Party Certification Laboratory Accreditation for Analyses of Foods Voluntary Qualified Importer Program Foreign Supplier Verification Program What is FSMA? The Food Safety Modernization Act is a complete overhaul of the Food Safety System that was designed to strengthen the US Food Safety System and prevent foodborne illness. Signed into law by President Obama on January 4, 2011, FSMA gives the Food and Drug Administration (FDA) enforcement power over the newly implemented rules and programs. The Food Safety Modernization Act provides a new approach that shifts the emphasis from responding to food-borne illness events to proactively preventing them at the processing and manufacturing level. From raw material production and supply to the distribution of finished products and raising animals, FSMA’s rules and programs are based on a farm-to-table concept that assures broad coverage across each business in the process. These rules and programs build on and complement one another to create a robust and effective Food Safety system that decreases the number of food-borne illnesses and helps protect your business’s reputation. They ensure a safe food supply for American consumers. Preventive Controls for Human & Animal Food The purpose of the Preventive Controls rule is to assure that food is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or misbranded under section 403(w) of the FD&C Act. The application of hazard analysis and risk-based preventive controls enables a proactive food safety system. It helps your facility protect both the food from potential hazards that may cause illness or injury to consumers if present in the food produced. The Preventive Controls rule has specific requirements including: A written food safety plan (FSP) A hazard analysis Preventive controls Monitoring Corrective actions Verification activities A Recall plan Maintaining associated records To meet these requirements, you will first need to designate a Preventive Controls Qualified Individual (PCQI). These individuals are responsible for developing and overseeing the implementation of the FSP, which is a dynamic document that needs to be reanalyzed every 3 years. You will also need to revisit this plan whenever changes in the product or process occur that impacts the food safety plan. If you have a HACCP plan in place, you must ensure that it complies with the requirements stated in 21 CFR Part 117 for human food or 21 CFR Part 507 for animal food. Distinctions in Preventive Controls When it comes to Preventive Controls for Human Food, this rule helps ensure: The finished product is protected against biological, chemical, and physical contaminants The food is safe for its intended use The product is not misbranded regarding labeling for allergens Regarding Preventive Controls for Animal Food, the rule works to ensure: Nutritional requirements for the intended species are met Finished products do not contain toxic components and are adequate for ingestion Prevention of biological contamination that can result in illness of the animal or the handlers of the food Food Traceability (FSMA 204) The Food Traceability rule outlined under FSMA 204 is intended to result in faster identification and removal of potentially contaminated food from the US market. Inconsistent traceability records, or lack thereof, causes delays during outbreak investigations and recall events which can result in more cases of illness or death. Through this rule, FDA has established record keeping requirements for high-risk foods listed in the Food Traceability List (FTL) and certain activities in the supply chain referred to as Critical Tracking Events (CTEs). This is to ensure that traceability information, referred to as Key Data Elements (KDEs), is kept. In addition to maintaining KDEs, the rule also requires a written Traceability Plan and the use of traceability lot codes. It’s also important to note that FDA may make changes to the Food Traceability List at any time. If they remove foods, the removal will be effective immediately. However, if they decide to include new foods, the change will take effect in 2 years, allowing time for industry to prepare. Critical Tracking Events & Key Data Elements FDA has identified steps in the supply chain called Critical Tracking Events. These are the instances where traceability records must be kept. CTEs for foods placed on the FTL can include everything from harvesting and cooling to shipping and receiving, among others. For every CTE, there are specific Key Data Elements that must be kept. General examples of KDEs include anything from business name and contact information to product description and quantity. Traceability Lot Codes The Traceability Lot Code is an important KDE that is defined as a descriptor — often alphanumeric — used to help track the food back all the way to its original source. When initially packing a raw agricultural commodity (RAC), land-based receiving of a food, or transforming a food, this FSMA rule requires the creation of a traceability lot code. Once the TLC has been assigned, it must stay the same unless the food is transformed. Therefore, simply transporting or holding food will not result in changes to the TLC. Intentional Adulteration The Intentional Adulteration rule— often referred to as Food Defense — helps with the implementation of mitigation strategies that target the vulnerabilities of specific types of process operations and a facility. This helps prevent individuals or groups of people from intentionally introducing a contaminant into food intended for human consumption, guarding against wide-scale harm to public health, including acts of terrorism. The Intentional Adulteration rule has outlined specific activities that are required to maintain FSMA compliance. This includes: Creating a written food defense plan (FDP) Conducting a vulnerability assessment Documented mitigation strategies Continued monitoring A list of corrective actions Verification activities Maintaining associated training and records A Food Defense Plan (FDP) has an approach similar to HACCP in conducting the identification and evaluation of significant vulnerabilities, and the actionable process step, where the mitigation strategies will be implemented. It’s important to note that vulnerability assessments must evaluate the following elements: The severity and scale of the potential impact on public health The degree of physical access to the product The ability to successfully contaminate the product The possibility of an inside attack A Qualified Individual must be designated as the person responsible for developing and supervising the implementation of the FDP. This document needs to be reanalyzed every 3 years. The identified vulnerabilities depend on the assessment conducted by a qualified individual and the efficiency of the mitigation strategies implemented. Companies have the flexibility to identify a mitigation strategy that is appropriate to their process and facility. Sanitary Transportation The Sanitary Transportation rule was established as part of the Sanitary Food Transport Act (SFTA) with outlines for its implementation established as part of FSMA. This rule institutes requirements for the shippers, carriers and receivers that transport human and animal foods to implement sanitary practices that help ensure the safety of food products. General Requirements for Sanitary Transportation Non-exempt shippers, receivers, loaders, and carriers that transport human and animal food in the United States must adhere to the following requirements: Vehicles & Transportation Equipment This regulation requires that transportation equipment be designed in a manner that does not cause the food to be unsanitary and unsafe for consumption. It also mandates that cleaning and maintenance practices for vehicles and equipment be in place to prevent contamination events. Transportation Operations This requirement includes the procedures that should be followed to ensure that the food is transported in sanitary conditions. These operations include procedures to control: Transportation conditions (temperature parameters) Cross contact prevention regarding allergen presence Cross contamination between ready to eat foods and raw foods Contamination between food items and non-food items Training Carriers and employees must be trained in sanitary transportation practices and maintain documentation that training has taken place. Records Records of procedures, training, and agreements must be maintained as evidence of compliance with the regulation. Produce Safety This rule was established as part of the FDA Food Safety Modernization Act to establish standards for growing, harvesting, packing, and holding of fruits and vegetables. The general purpose of produce safety is to reduce microbial contamination to help prevent foodborne illnesses in fresh foods. Produce — vegetables and fruits — can be divided into 2 groups, based on how the rule applies to them. These groups are covered produce and not covered produce. Covered produce are fruits and vegetables that are considered raw agricultural commodities. These commodities are foods that will be consumed raw without any other treatment that can eliminate microorganisms. This includes fruits, leafy greens, herbs and nuts. Think of anything that you would eat as a salad or snack or in general any fresh fruit and vegetable that does not require cooking before consumption. Produce that is not covered by the rule is, in general, not consumed raw. This includes beans, asparagus, potatoes, corn, and other vegetables that need to be cooked before they are consumed. Standard Requirements for Produce Safety The Produce Safety Rule has established minimum standard requirements that must be followed by growers to limit the potential for biological contamination from the environment in fresh produce. They are as follows: Employee Health & Hygiene Employees must be trained in topics such as personal hygiene, food safety, work safety, the appropriate processing for packaging, holding, growing and any steps that are taken during the production process to help minimize the potential of contaminating the fruits or vegetables. Agricultural Water Quality This regulation states that the water used to irrigate produce must be safe and adequate, meaning that it is free of microorganisms that can cause food-borne illnesses. Animals Action must be taken to minimize the presence of domestic or wild animals in the fields to limit the potential of contamination. Biological Soil Amendments A soil amendment is defined as a material added to the soil to improve its chemical or physical conditions. Usually, growers use manure or other types of biological matter to mix with their soil. As this can be a source of microbial contamination for fresh produce, FDA has established specific standards for the use of these types of amendments. Equipment & Tools Equipment and tools used during harvesting and packaging should be kept in good condition and follow cleaning and sanitation practices to minimize the potential for contamination events. Buildings Structures should be designed in a way that separates raw product from cleaned and processed products as this further limits potential contamination. Sprouts Due to how sprouts are grown and harvested they create favorable conditions for pathogens to grow and historically have been linked to many outbreaks and recalls. This specific section of the produce safety rule was developed to ensure that sprouts are grown, harvested and packaged in conditions that prevent contamination from the environment. Accredited Third-Party Certification A voluntary program, Accredited Third-Party Certification was established by FDA to set forth and regulate how FDA will recognize accreditation entities. It also details how those accreditation entities will accredit certification bodies, and how certification entities will conduct food safety audits and issue certifications for individual food facilities. This rule allows accredited certification bodies to plan and conduct unannounced audits of food facilities. These bodies may also monitor certified facilities in the event of suspected non-compliance and even immediately address deficiencies with corrective actions. Advantages of an Accredited Third-Party Certificate Under the Preventive Control and FSVP rules, facilities and importers can choose on-site audits for supplier verification. While not a requirement, having a certificate from an accredited third-party entity can be beneficial in two instances: An importer wants to establish themselves within the Voluntary Qualified Importer Program (VQIP). This program requires the importer to collect and maintain accredited third-party certifications for each foreign supplier’s facility. FDA may require an imported product to have such a certificate. FDA will base their import certificate decision on the following factors: Food safety risks of the food and its origin Evidence of an inadequate food safety system Laboratory Accreditation for Analyses of Foods (LAAF) Ever since LAAF’s establishment in February 2022, only FDA recognized and accredited laboratories are able to conduct food testing for the various circumstances defined by this rule. The Laboratory Accreditation for Analyses of Foods Program covers food testing for: Removal of a food from an import alert Admission of imported foods Testing requirements for sprouts, shell eggs, and bottled drinking water Directed food laboratory orders Evidence for mandatory food recalls, suspension of facility registration, or detention appeals The establishment of the LAAF program empowers FDA’s ability to protect US consumers from potentially unsafe food. It improves the accuracy and reliability of certain food testing through uniform standards and the enhanced oversight of accredited laboratories. Voluntary Qualified Importer Program (VQIP) The Voluntary Qualified Importer Program (VQIP) is an optional, fee-based, FSMA program that provides benefits to eligible importers during the entry process to expedite the review and importation of food. The entry system is designed to recognize and have US Customs immediately release the line entries covered under VQIP after entry documents are submitted. This program only applies to importers and foods for which an application was submitted to FDA and deemed in compliance with the applicable requirements. To be accepted into the Voluntary Qualified Importer Program, importers must demonstrate a high level of control over the safety and security of their supply chains. Their foreign suppliers must also undergo and pass inspections by a certifying body approved under the FDA’s Third-Party Certification Program. Foreign Supplier Verification Program (FSVP) The Foreign Supplier Verification Program (FSVP) rule expands the responsibility of ensuring the safety of imported foods to include US importers. It no longer places that responsibility solely on the foreign manufacturer’s shoulders as with other rules like Preventive Controls and Produce Safety. Before FDA instituted FSVP, many US importers’ food safety systems included procedures for verifying the safety of their imported food but not all. With the establishment of the FSVP rule, the FDA now has enforcement power to inspect US importers of human and animal food and verify 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 It’s also important to note that each FSVP implemented is unique to the supplier, the product, the process and the importer. Creating an FSVP also involves various key considerations to assure compliance with the program. These include everything from where a supplier is based and if FDA recognizes their food safety system, to where in the supply chain hazards are controlled and if the importer is subject to other FDA regulations. The Foreign Supplier Verification Program has several other key considerations deserving of an importer’s attention. We cover these in detail and the 8 simple steps to assure continued FSVP compliance in our complete guide, FSVP 101: Everything You Need to Know As An FSVP Importer. How to Simplify FSMA Compliance The Food Safety Modernization Act is here to help protect consumers from potential hazards and to help track issues throughout the supply chain. FDA takes compliance with these rules very seriously and missing critical procedures or safety measures required of your business can cause irreparable damage to your reputation and your bottom line. You can easily achieve full FSMA 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 master FSMA with Registrar Corp’s industry leading compliance solutions.

Detention Assistance and Import Alert Updates

Facilities located outside the U.S. that refuse an FDA inspection may be placed on Import Alert 99-32: Detention Without Physical Examination (DWPE) of Products from foreign establishments refusing FDA inspection. Not only does this import alert allow the Administration to seize your items, it places your establishment on an FDA Red List. Any products from facilities added to the Red List are subject to refusal of admission according to section 807 B of the FD&C Act until the facility has documented proof of an inspection. What is an Import Alert? Import Alerts occur when the Food and Drug Administration (FDA) notices a pattern of non-compliance from a particular company, country, or product type. They inform both FDA's field staff and the general public that the Administration has enough evidence to permit DWPE of products that appear to be in non-compliance and violation of FDA regulations. Delayed or refused shipments resulting from Import Alerts and their respective FDA Red List can strain relationships with buyers, damage a brand’s reputation, and can greatly affect revenue. We strongly advise establishments to accept an inspection without hesitation. FDA may issue a Notice of Inspection at any time. You should prepare by assuring your facility is compliant with FDA Current Good Manufacturing Practices (cGMPs) and other regulatory requirements as other violations may warrant further field examination. What is the Purpose of an Import Alert? Import alerts are intended to help prevent products suspected of FDA violation from being distributed in the United States. They free-up agency resources for the physical examination of products from other shipments. Import Alerts also provide uniform coverage across the country. Import Alerts also place responsibility firmly with the importer. This is to assure that products being imported into the United States are in full compliance with all FDA's laws and regulations. What Types of Import Alerts Are There? A product can be placed on an Import alert based on how the product is made or based on issues with the product itself. Import alerts are usually categorized as: Country or Area Wide FDA may detain without physical examination various products intended for distribution in the U.S. from a specified country or area. For example: Import Alert 12-03, DWPE of Imported Soft Cheeses and Soft Ripened Cheeses from France. Country or Worldwide FDA may also detain without physical examination certain products from any and all countries outside of the U.S. for various reasons such as: Import Alert #16-20, DWPE of Puffer Fish. Due to the fact that the toxins in Puffer Fish cannot be destroyed by cooking or freezing, FDA restricts import of this product from any and all sources, worldwide. Shipper Products from various shippers may also be subject to DWPE by FDA due to factors such as contamination or adulteration. An example: Import Alert #16-105, DWPE of Seafood and Seafood Products from a specific manufacturer or Shipper due to Histamines. Manufacturer & Product Specific As with the case of Import Alert 99-32, FDA also retains the right to detain without physical examination specific products from a manufacturer. Other examples of this include: Import Alert 89-16, DWPE of Products from Medical Device Firms that refused FDA Inspection. Import Alert 99-37, DWPE of Low-acid Canned Foods and Acidified Foods that do not have Filed Scheduled Processes. FDA Inspections of Foreign Food Facilities FDA requires food facilities to respond to inspection requests within 24 hours and the Agency may interpret a lack of response as refusal of inspection. It’s also important to keep in mind that FDA communicates an inspection request with a facility’s U.S. Agent in charge. It’s prudent to designate a reliable Agent to avoid miscommunication or late responses. When preparing for an inspection, it is sound strategy to familiarize yourself with common FDA violations so you can assure the same mistakes aren’t made at your facilities. For customized preparation assistance, Registrar Corp can dispatch a Food Safety Specialist to your facility to conduct a Mock FDA Inspection. As part of this inspection service, our Specialist will help identify potential food safety issues in the structure, processes, procedures and documentation used in your daily production. What to Do When You’re on FDA Red List for Import Alert 99-32 To be removed from an Import Alert 99-32 and its red list, a facility is required to petition for FDA inspection. FDA states that it may be at least a year before FDA can return to inspect a facility that initially refused. Given this, full cooperation with FDA inspection is critical in avoiding loss of revenue from an otherwise avoidable Import Alert. To remove a brand’s product from the FDA Red List, information should be provided to the Agency to demonstrate that the firm has completed FDA inspection and meets the criteria for removal. The process requires you to provide sufficient evidence of your corrective actions. It may also require multiple compliant shipments to be reviewed by FDA’s Division of Import Operations. 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 know how to help you submit the most complete and evidence-based petition for removal and keep your products out of detention. Discover how Registrar Corp helps keep your business off Import Alerts and avoid disruptions.

Food & Beverage

The FDA List of Allergens establishes a guidepost that helps the Administration regulate food and beverage companies in how — and what — ingredients are listed on their packages. When it comes to food, allergic reactions vary in severity from mild symptoms to more severe, life-threatening anaphylaxis. For this reason, with certain foods or substances that cause allergies or other allergic reactions, there are specific labeling requirements enforced by FDA that companies should be aware of. What Are FDA Food Allergens? According to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), a food allergen is an ingredient in any food or beverage that triggers a mild to severe immune system response in reaction to certain proteins that are present in the ingredient. Due to the prevalence, potential severity, and threat to public safety that these allergens represent, FDA has established guidance for the food industry and its consumers on how to identify and manage allergen hazards in both food and beverages. How Is the FDA List of Allergens Used? FDA updates and uses their allergen list to help conduct inspections and establish various labeling controls to prevent undeclared allergens during the manufacturing and packaging process of foods or ingredients. They will sample products to check that FDA Food Allergens are properly labeled on products and even determine if food facilities are implementing proper controls to prevent allergen cross-contact for items on the list. When food safety issues are identified in relation to the presence of a food allergen, FDA enforces product recalls and will immediately notify the public, or may even issue an Import Alert, seize and remove violative products from the marketplace, or simply refuse entry of imported products. The FDA List of Allergens: 9 Major Regulated Foods There are now 9 major FDA food allergens that together cause more than 90% of food allergies in the U.S. Each year, these foods cause about 30,000 consumers with food allergies to need emergency room care. Worse, 150 individuals die each year due to severe reactions from food allergens. It is for this reason FDA enforces any packaged food containing these allergens to declare the ingredients on its label to warn its consumers. Here is the current list of Major FDA Food Allergens: Crustaceans Crustacean shellfish consist of softshell seafoods that are non molluskan. They are aquatic animals that have jointed legs, a hard shell, and no backbone. Some foods in this group are: Lobster Shrimp Crab Crayfish Prawn Krill Fish Allergies to finned fish is more common in adults than children and affects roughly 1% of the world’s population. Some of the fish FDA closely monitors and regulates as allergens are: Haddock Cod Tilapia Tuna Salmon Perch Flounder Peanuts Despite its name, a peanut is actually a legume, not a nut. Although there are four main varieties of peanuts, all peanuts come from the same plant, Arachis Hypogaea. The most common variety is the Runner. This peanut makes up 80% of what is grown in the U.S. and is what most manufacturers use to create peanut butter and peanut confections. Tree Nuts Tree Nuts is a broad category that covers many foods that are used as ingredients and those that are not. FDA & the FALCPA considers the following foods as allergens under the Tree Nut category: Almonds Cashews Pecans Walnuts Macadamia Pistachio And many others Milk When it comes to Milk, most allergens arise out of the proteins Whey and Casein. Though most commonly associated with cow’s milk, allergic reactions can occur with other common milks such as goat, sheep, and buffalo. Unlike an intolerance that doesn’t involve the immune system, milk allergies are most common in children and can be as mild as nausea to severe and life-threatening as anaphylaxis. Eggs Chicken eggs are the most common cause of an egg allergy, the proteins found in the whites and yolk triggering a mild to severe reaction. However, other animal eggs, such as duck, turkey, or even quail, may cause a consumer’s immune system to overreact. Wheat When FDA talks about “wheat” they refer to any plant species of the genus Triticum. This genus includes the following grains: Spelt Kamut Triticale Semolina Einkorn Emmer Common Wheat Durum Wheat Sesame Sesame allergy is growing at a much faster rate in the U.S. than other food allergies and is estimated to be as common as fish allergies, soy, and even some tree nut allergies. Due to the rapid growth of sesame allergy, this seed is officially the ninth major food allergen recognized by FDA. Soybeans Like peanuts, soybeans are a legume that are used in a variety of common foods such as tofu, soy sauce and milk, natto, and miso. Allergic reactions to soy are generally mild and, although rare, severe and potentially life-threatening reactions do occur. Labeling Requirements for FDA Food Allergens The Administration requires that all food labels identify any source of major FDA food allergens that are used to make the food in the package. This requirement is considered met if the common name of an ingredient identifies that allergen's food source name. FDA also requires that the type of tree nut, the species of fish, and species of crustacean to be clearly named. There are two ways an allergen’s food source can be declared on the label: In parentheses following the name of the ingredient. Ex: flour (wheat), whey (milk), and lecithin (soy). Immediately after or next to the ingredient list in a clear and prominent contains statement. Ex: “Contains wheat, milk, and soy.” How to Assure Compliance With FDA Food Allergens Registrar Corp has spent 20 years assisting over 30,000 companies each year navigate the complexities of FDA compliance across 175+ countries. We know how to help you meet the stringent federal labeling requirements and prepare your products for the U.S. market. With our Label Review service, you have the ongoing support of a professional label compliance partner. Discover how quick and easy it is to gain and maintain compliance with FDA food allergen labeling requirements.   Frequently Asked Questions Does the FDA consider coconut an allergen? FDA recognizes coconut as a tree nut, and thus an allergen that must be declared. This can be confusing for some, as coconuts are technically considered to be fruits and there are few instances of people being allergic to both true tree nuts and palm coconuts. Does the FDA consider sesame an allergen? Yes. As of 2023, sesame is the ninth major FDA food allergen as recognized in the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, a federal law passed in 2021. How does the FDA differentiate between food sensitivities and food allergies? A food sensitivity or intolerance does not involve the immune system. A food allergy occurs when immune cells bind with certain proteins found in a particular food and trigger a mild to severe histamine response.

Medical Devices

Before marketing a Class I medical device — or even a Class II or III — in the United States, manufacturers should first gain a solid understanding of how the U.S. Food and Drug Administration (FDA) classifies each medical device. Simply put, FDA divides medical devices into classes to determine the regulations a device is subject to. They provide a blueprint for the path to legally marketing that device in the U.S. The Administration regulates all medical devices marketed in the U.S.. It assigns every single device a classification based on the possible threat it poses to the health and safety of a patient should something go wrong with it. FDA has classified over 1,700 unique types of medical devices. They are listed in the Code of Federal Regulations (CFR) under 16 specialties (also known as panels). Classifying a device according to one of the 16 panels is beginning of understanding whether you are manufacturing a Class I medical device, or a Class II or III. What Are FDA Medical Device Classifications? Medical device classifications indicate what controls apply to a device and what regulatory submission, if any, is needed to market the device. When a device is subject to certain controls and/or submission requirements, these requirements must be strictly adhered to. If a manufacturer markets a medical device without applying the applicable controls or obtaining approval for applicable regulatory submissions, FDA considers the device to be adulterated or misbranded and the device is subject to FDA’s enforcement actions. Class I Medical Devices Class I medical devices maintain little contact with a patient and have minimal impact on their overall health. Typically, these devices do not influence or interact with a patient's internal organs, circulatory, or central nervous systems. Almost half — 47% — of medical devices fall under Class I and roughly 95% of these are actually exempt from the regulatory process. If a medical device is considered exempt, a 510k premarket notification and premarket approval (PMA) is not required before marketing the device in the U.S. However, the manufacturer must register their establishment and their products with the FDA. They are also required to comply with the same FDA General Controls which apply to each Class of medical device which enforce adulteration, misbranding, device registration, records, and good manufacturing practices. Class I Medical Device Examples Examples of Class I Medical Devices include enema kits, stethoscopes, and latex gloves. Other examples include: Bandages Bedpans Tongue depressors Surgical masks Irrigating dental syringes Class II Medical Devices Class II medical devices present a higher amount of risk due to the fact that they are more likely to come into sustained contact with a patient. For this Class, general controls are not enough to provide adequate assurance of the safety and effectiveness of the device and FDA places additional Special Controls on them to help enforce proper safety. Special Controls depend on the individual device and may include unique labeling requirements or performance standards. These medical devices are considered Class II devices and comprise 43% of all medical devices in the U.S. market. Class II Medical Device Examples Examples of Class II devices include surgical gloves, contact lenses, and some pregnancy test kits. Other examples of these products include: Blood pressure cuffs Syringes Blood transfusion devices Powered wheelchairs Contact Lenses Class III Medical Devices Medical devices classified as Class III are those that pose a moderate to high threat to the patient's safety. They generally sustain or support life, are implanted into the patient, or present a potential of unreasonable risk of illness or injury. About 10% of medical devices are categorized as Class III and General and Special Controls are not enough to assure the safety of these devices. Products that fall in this category are subject to additional FDA measures like premarket approval. Class III Medical Device Examples Class III medical devices include products like implantable pacemakers and breast implants. Other examples include devices such as: Defibrillators High-frequency ventilators Cochlear implants Fetal blood sampling monitors Implanted prosthetics How to Determine What Your Medical Device Class Is FDA has categorized well over 1,700 unique types of medical devices. They have organized each in the electronic Code of Federal Regulations (eCFR) into groups known as 'specialties'. Identifying which of these specialties your medical device falls into is generally the first step in understanding whether you are manufacturing a Class I medical device, a Class II, or a Class III. The 16 Specialities, or “Panels,” listed in alphabetical order are: Anesthesiology Cardiovascular Chemistry Dental Ear, nose and throat Gastroenterology and urology General and plastic surgery General hospital Hematology Immunology Microbiology Neurology Obstetrical and gynecological Ophthalmic Orthopedic Pathology Physical medicine Radiology Toxicology Classifying your Medical Device typically begins by selecting your Specialty/Panel. By selecting your respective panel, you will be sent to an array of devices that fall into that category. For example , if you’re looking to identify the classification of a blood pressure cuff, you would select the Cardiovascular category followed by “Blood Pressure Cuff” under cardiovascular diagnostic devices. Once you click the Blood Pressure Cuff, you will be sent to the device information page. It is here under “Classification” that you can see that blood pressure cuffs are categorized as Class II medical devices for performance standards. Make Medical Device Compliance Quick & Easy Whether you're bringing a Class I Medical Device to market or a Class III, compliance can be tricky. From accurately identifying device classification to complying with a changing regulatory landscape, getting it right can be a time-consuming and complicated process. It doesn’t have to be. Registrar Corp has spent over 20 years helping more than 30,000 companies each year across 175+ countries navigate the complexities of FDA compliance. We know how to help you quickly bring your medical devices to market. Discover how simple Medical Device compliance can be.

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