Hydroxocobalamin is used as an antidote to cyanide poisoning. “Primary intended purposes” in the definition of device, 3. Classification of products is the first step in any regulatory review process at the Health Products and Food Branch (HPFB). 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? While issues have arisen relating to whether a product should be classified as a drug, device, biological product, or combination product, most of these issues have related to whether a product should be classified as either a drug or a device. 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. Search for FDA Guidance Documents, Recalls, Market Withdrawals and Safety Alerts, Search General and Cross-Cutting Topics Guidance Documents, Classification of Products as Drugs and Devices and Additional Product Classification Issues, Frequently Asked Questions About Combination Products, How to Write a Request for Designation (RFD), webpage for the Office of Combination Products, How to Prepare a Pre-Request for Designation (Pre-RFD), Biosimilars:  Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009, Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009. The resin undergoes anionic polymerization in the presence of water. The examples presented in section III.B.5 offer illustration of FDA’s interpretation of chemical action. 9, FDA’s determination of whether to classify a product as a drug or device is based on statutory definitions, as set forth in sections 201(g) and 201(h) of the FD&C Act, respectively. Classification product codes are used by FDA to obtain quality and reliable data, and perform analyses that are often reported to Congress, the … For example, we have determined that chemical action occurring solely within an extracorporeal device, specifically a kidney hemodialysis machine, is not occurring within or on the body. General informationLearn more about FDA Product Classification Database, Original dataset downloadsProduct Classification Database download information. 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. It will be interesting to see the effect of this case on FDA’s classifications going forward. FDA Classification of Skin and Wound Care Products. 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. 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). 3. For this data set, FDA is specifically disclosing the final inspection classification for inspections conducted of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed. 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. This database contains device names and their associated product codes. The name and product code identify the generic category of a device for FDA. The aim of drug classification is to ensure that you use a drug safely to achieve the utmost benefit. While the product binds to tissue, it does not exhibit pharmacological action because that binding does not mediate a bodily response. 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. If sponsors have questions regarding the Agency’s interpretation of this clause, they may contact OCP. 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. For a medical product also to meet the more restrictive device definition under section 201(h) of the FD&C Act, it must (i) be “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article,” and (ii) “not achieve its primary intended purposes through chemical action within or on the body of man or other animals” and (iii) “not [be] dependent upon being metabolized for the achievement of its primary intended purposes” (emphasis added). FDA Documents - More Information. “Similar or related article” in the definition of device, 2. 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. If the Agency does not provide a written response within sixty days, the sponsor’s recommendation respecting the classification of the product is considered to be the final determination. The sponsor presumably has the most complete information relevant to how its proposed product achieves its primary intended purpose(s). For further information regarding the definition for the term combination product and the regulation of combination products, please visit the webpage for the Office of Combination Products. This binding is a pharmacological action because it disrupts the integrity of the bacterial membrane, which causes organism death, thereby treating the bacterial infection. The FDA Product Code describes a product or a group of products. 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 note that “classification” as used in this guidance refers to a product’s designation as a drug, device, biological product, or combination product. For further information on the classification of products as devices, drugs, biological products, or combination products, please refer to the Frequently Asked Questions on the next page, OCP’s webpage, or contact OCP at: Office of Combination Products The issue of whether a product may be considered a “similar or related article” under this clause can arise, for example, with regard to products in liquid, semi-liquid, gel, gas, or powder form. The mere exchange of non-chemical energy (e.g., electromagnetic or thermal energy) between a product and the body would not constitute “chemical action.”. 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