This webinar will provide understanding of regulatory requirements of veterinary medical device; how to differentiate regulations of human and veterinary medical devices, manufacturing requirements, safety standards, labelling requirements; and how to draft the SOPs covering material intake, production, quality control, packing, distribution and sales.
Why Should You Attend:
The U.S. Food and Drug Administration’s Center for Veterinary Medicine (“CVM”) is responsible for the regulation of veterinary medical devices intended for use with both family pets and food-producing animals. The Federal Food, Drug, and Cosmetic Act (“FDCA” or “the Act”) does not include separate and distinct definition for the term “veterinary medical device.” Instead, the FDCA contains and FDA relies on a single universal definition for the term “medical device” that covers such products for both humans and animals.
To market and sell a veterinary medical device in interstate commerce, a manufacturer must insure that the item has been safely manufactured and properly labeled. CVM has regulatory jurisdiction over veterinary medical devices and has shown little interest in the market sector based on the existence of historical enforcement action. However, with the growing marketing and promotion of injectable devices for horses and dogs, it is possible that such enforcement discretion may be abandoned for greater regulatory scrutiny and oversight.
This webinar is designed to provide attendees with an overview of FDA’s regulation of veterinary medical devices and to provide insight into how the market may develop in the future.
For more information on the training, please click here.