Please note that “classification” as used in this guidance refers to a product’s designation as a drug, device, biological product, or combination product. The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. What Is the Process For Obtaining a Formal Classification Determination for a Product? FDA Center for Veterinary Medicine. 3. Under the Agency’s interpretation of the device definition, a product exhibits “chemical action” if it interacts at the molecular level with bodily components (e.g., cells or tissues) to mediate (including promoting or inhibiting) a bodily response, or with foreign entities (e.g., organisms or chemicals) so as to alter that entity’s interaction with the body. Therefore, this effect is not achieved through chemical action. The first clause of the device definition provides that the term “means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article . FDA classification, medical devices I Devices used by and easily accessible to the public; regarded as having minimal potential for incorrect use when used in health care II Must undergo an approval process that includes special controls, eg performance standards and general controls required of all devices However, products that meet the device definition may be regulated as drugs or biological products in some cases. “Chemical action” in the definition of device, 4. Similarly, we have determined that the chemical action of a transport solution to preserve a donor organ for transplantation while in an organ transport container is not occurring within or on the body. Respirator Mask with Antimicrobial Filter. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required. Can a product be classified as a device if it exhibits “chemical action”? Now you need to find the applicable product codes. The FDA Product Code describes a product or a group of products. A resin that fills a cavity in a tooth as part of the treatment of dental caries may bind to the tooth via covalent bonding, or rely in part on intermolecular forces to change from liquid or paste to solid form. I've been poking around in the FDA's Product Classification database and in MAUDE. Therefore, it would not be considered chemical action. Then it somehow became very important - never understood that. FDA Product Classification. Because a device “does not achieve its primary intended purposes through chemical action within or on the body of man or other animals” (emphasis added), a product can be a device even if it achieves its primary intended purposes through chemical action, so long as the chemical action does not occur “within or on the body” (and the product meets the other elements of the definition of device under section 201(h)). Please note that “classification” as used in this guidance refers to a product’s designation as a drug, device, biological product, or combination product. It will be interesting to see the effect of this case on FDA’s classifications going forward. For example, for a sponsor seeking to classify its proposed product as a device, those data should demonstrate that its product meets the definition of a device. While the sponsor should justify why it believes the product meets the recommended classification, we generally consider both the information provided in the RFD and other information available to the Agency at that time in making our designation. Accordingly, we do not offer guidance on its construction here. 21 USC 360bbb-2(b) and (c).8. Alternatively, you may first identify the panel (medical specialty) to which your device belongs to. The guidance’s discussion of the classification of products is also relevant to classification of the constituent parts of a combination product. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. This kind of product, which has become a habit and for which you don’t think too much before buying are part of the convenience goods cat… If you find more than one possibility, then you will need to repeat this process for each. “Similar or related article” in the definition of device. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This could be the case, for example, for gels or powders put on the skin as a barrier, gases used as space fillers, or liquids used to clean either surgical instruments or contact lenses. Distinct considerations may apply in determining how to classify a product intended for use in animals. The resin undergoes anionic polymerization in the presence of water. Sponsors seeking a classification determination should present all available data and other information potentially relevant to that determination (without regard to whether the data or information supports the sponsor’s preferred outcome). 12. 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Site best viewed using Chrome and Firefox browsers. The US FDA has established classifications for approximately 1700 different generic types of devices and categorized in 16 medical specialties. Rockville, MD 20852. Section 201(g) of the FD&C Act (21 USC 321(g)) provides that the term "drug" means: (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C). Accordingly, such an implant could be classified as a device despite the chemical action, because such action does not achieve the product’s primary intended purpose. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 14. I know the requirement is in 211.180e, but as we all know it is very vague. This guidance focuses on classification of products for human use. Specifically, FDA’s Draft Classification Guidance stated that (1) any therapeutic effect by a product would be considered a “primary intended purpose” pursuant to FDC Act § 201(h), and (2) if a product that depends “even in part” on chemical action within or on the body to achieve a primary intended purpose, it is excluded from the device definition. FDA will publish an order announcing the new classification and the appropriate controls, as well as a decision summary that is publicly available. It is composed of a cationic protein surfactant that has fatty acid functional groups. Whether chemical action is occurring “within or on the body” is generally a straightforward matter. This may seem easy, but identifying the closest FDA predicate device to yours among thousands of codes is often harder than it seems. OCP will provide you feedback, including on whether a pre-RFD or an RFD may be appropriate and what information you should provide. Section IV provides contact information for OCP and responses to frequently asked questions. This database includes: a list of all medical devices with their associated classifications, product codes, FDA Premarket Review organizations, and other regulatory information. The regulatory authorities recognize different classes of medical devices based on their potential for harm if … Once OCP determines the RFD is complete for filing, the Agency reviews the RFD. This is distinct from the use of the term “classification” in reference to the class (Class I, II, or III) of a device as described in section 513(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). .” (emphasis added). 9. Learn more about the FDA and submission process in our FDA … Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions). 3. This database contains device names and their associated product codes. For example, if the primary intended purpose of a hip joint replacement implant is to restore movement, and the implant also elicits a foreign body response through chemical action, that response would not be considered a primary intended purpose of the implant. Magnesium sulfate is used as replacement therapy for magnesium deficiency. Generally, the product would be classified as a device, unless it falls within a special category (for example, apparatuses used in the preparation of compounded positron emission tomography drugs are classified as drugs, see 21 USC 321(ii)). This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. Further, the FDA’s decision does not mean IQOS is risk-free. At Enzyme, our industry experts provide easy to understand explanations for complex regulations.Our mission is to help life science companies commercialize faster without compromising patient care. What should you do if, after reviewing this guidance, you are unsure of how your product is classified? This guidance is intended to provide the Agency's current thinking on approaches for classifying products as drugs and devices, and on certain additional product classification issues. Yes, if the product does not achieve its primary intended purposes through chemical action within or on the body and otherwise meets the definition of a device. PMMA is an acrylate polymer that is used as a temporary bone spacer. For additional information on how to submit an RFD, see How to Write a Request for Designation (RFD). FDA regularly receives questions from medical product sponsors concerning the classification of their products. 2 We believe that efficient, effective regulation is facilitated by providing guidance on issues frequently raised in relation to Requests for Designation (RFDs) and other classification activities. All comments should be identified with the title of the guidance. which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. To discuss an alternative approach, contact the FDA office responsible for this guidance listed above. If sponsors have questions regarding the Agency’s interpretation of this clause, they may contact OCP. If you find more than one possibility, then you will need to repeat thi… Product Code: PSW: Premarket Review: Surgical and Infection Control Devices (OHT4) Infection Control and Plastic Surgery Devices (DHT4B) Submission Type: 510(k) Regulation Number: 892.1570: Device Class: 2 Total Product Life Cycle (TPLC) TPLC Product Code Report: GMP Exempt? Product classification and nomenclature in the global healthcare sector is quite complex for many reasons. “Within or on the body” in the definition of device. If the product has more than one name (e.g., a fish known under several regional names), the Product Code may have several different synonymous definitions associated with it. Helius Medical Technologies, Inc. FDA Product Classification Codes Begining with "W" A B C D E F G H I J K L M N O P Q R S T U V W X Y Z. FDA Device Classification: Medical Specialty: FDA Product Code Please contact OCP if you have questions regarding whether to submit an RFD, what information to provide, or issues to address in an RFD to ensure its completeness and clarity. FDA Product classification is based on many things including, the product ingredients, claims, and application. WD can effectively review and evaluate the FDA standards of your product and make sure the proper classification is made available to US customs. For example, if a vaginal product is intended solely to facilitate ease and comfort during sexual intercourse and it achieves this through lubrication that decreases friction (via mechanical/physical action) and not through chemical action, it is classified as a device. The sponsor presumably has the most complete information relevant to how its proposed product achieves its primary intended purpose(s). The following chart describes these three classifications, and also gives examples of each. The “fraud on the FDA” claim that the Supreme Court held preempted in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), was actually the most extreme form of a private plaintiff second-guessing the result of an FDA process classifying a regulated product. The following examples further illustrate the application of some of the key provisions of the device definition discussed above. This guidance is organized into two substantive sections. Food and Drug Administration See Section 7002(e) of the Biological Price Competition and Innovation Act of 2009; see also FDA, Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009. The FDA describes the Product Code Classification Database in the following way: "The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. This database contains device names and their associated product codes. However, the same product can be classified as a drug if it is intended, for instance, to alter pH, control odor, or prevent infection, and does so through chemical action as discussed in III.B.3 above. However, the Agency has on occasion considered some situations in which it may be less clear whether chemical action is occurring within or on the body. Classification of products is the first step in any regulatory review process at the Health Products and Food Branch (HPFB). The following discussion presents the Agency’s current thinking on certain issues that arise with respect to the statutory definition of device. Where can you find additional information about product classification? If unable to submit comments online, please mail written comments to: Dockets Management Based on the first variable, the shopping habits, the products can be classified into convenience goods, shopping goods and unsought goods. The term “biological product” means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), 13 or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings. FDA product labels provide Professional Information about drugs. 4. In addition, products that meet the drug definition, or both the drug and device definitions, may also meet the definition of biological product under section 351(i) of the PHS Act (42 USC 262(i)). Basis for classifying. . “Similar or related article” in the definition of device, 2. A basic overview of each product is provided (including dosages, possible drug interactions, side effects and contraindications) along with safety and/or efficacy ratings. . We apply these definitions to products, relying on the scientific data that are available to FDA at the time of the classification determination concerning the product for its proposed use(s)/indication(s).10. 1-62 ISO 5356-1 Third edition 2004-05-15 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets; 1-98 ISO 80601-2-12 First edition 2011-04-15 Instead of narrowing their definition of “primary intended purpose,” however, FDA adopted an entirely new strategy. No Summary Malfunction Reporting: Ineligible: Implanted Device? I have seen several documents about what should be included in an Annual Product Review (APR); however, I am looking for the FDA Guidance document for the preparation of an APR. You can then review each individual code to determine the best option for your product by clicking on each code. General informationLearn more about FDA Product Classification Database, Original dataset downloadsProduct Classification Database download information. A physiological effect (i.e., cell death) results from heat transfer, not from a binding interaction with the gas. Accordingly, such an absorbable suture could be classified as a device despite the chemical action and metabolic activity, because such action or activity does not achieve the product’s primary intended purpose. This database contains device names and their associated product codes. Therefore, the freezing is not considered chemical action. 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