The global veterinary and animal equipment market is growing with an estimated compound annual growth rate (CAGR) of 8.0% in this 2015 to 2020 time period. This growth is largely coming from North America, driven by an increasing animal population, increasing animal health expenditure and pet insurance claims, and growing adoption of advanced diagnostic procedures in small and large animal practices. Additionally, there is an increase in the global demand for animal food products. All these market changes are driving forward a relatively immature animal products market with an interesting and accessible regulatory environment.
In general, products to be used in the clinic or by animal owners to help treat or prevent a disease or condition in animals with a mechanical action are considered to be Medical Devices under the Food, Drug and Cosmetic Act in the United States. Some simple examples of these include needles, surgical instruments, or prosthetic devices. While these examples are clearly medical devices, in some cases it is not clear cut such as with diagnostic kits and screening tests for drug residues, among others. In these cases, proper classification of products is key, as the outcome of this classification will significantly impact your regulatory burden.
Medical Devices for animals as per the Food, Drug and Cosmetic Act cannot be misbranded or adulterated. For example, you must have clear and understandable directions for use, and your safety for both humans and animals must be established. It is the responsibility of the manufacturer and/or distributor of these products to ensure that these animal devices are safe, effective, and properly labeled. There is no pre-market approval for these products. If they are found to not be safe, the FDA can take regulatory action since these products are covered under the Food, Drug and Cosmetic Act.
A variety of product types for animals exist such as pesticides, supplements, feed, drugs and devices, as aforementioned. Which category your product falls under depends on your marketing strategy and how the product functions, which drastically impact your regulatory burden. The regulatory path to market for animal products ranges widely, from a full regulatory pre-market FDA submission to no FDA oversight at all as in the case for grooming aids with a cosmetic type purpose like “coat sheen appearance”.
There is relatively little guidance available to industry on animal products, yet the consequences can be significant for non-compliance. For assistance with your animal product as you bring them to the US market—whether it be new devices, supplements or even feed ingredients, contact dicentra today.
dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences, food and cannabis industries. We can be reached at 1-866-647-3279 or info@dicentra.com.
References
Katore, R. S. (2016, August 11). Global Veterinary Diagnostics Devices Market | Future Analysis by Product, Technology, by Animal. Retrieved from https://www.linkedin.com/pulse/global-veterinary-diagnostics-devices-market-future-analysis-katore
(n.d.). Retrieved from https://www.avma.org/KB/Policies/Pages/Unapproved-New-Animal-Drugs-Marketed-as-Devices.aspx
Markets, R. A. (2016, April 04). Global Veterinary/Animal Equipment Market Outlook: 2016-2021 – Market is Expected to Grow at a CAGR 8.0% – Research and Markets. Retrieved from https://www.prnewswire.com/news-releases/global-veterinaryanimal-equipment-market-outlook-2016-2021—market-is-expected-to-grow-at-a-cagr-80—research-and-markets-300245339.html
Medicine, Center for Veterinary. “Resources for You – Animal Products FDA Regulates.” U S Food and Drug Administration Home Page, Center for Biologics Evaluation and Research, www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm268125.htm.
Medicine, Center for Veterinary. “Resources for You – How FDA Regulates Veterinary Devices.” U S Food and Drug Administration Home Page, Center for Biologics Evaluation and Research, www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm047117.htm.