This webinar will make your understand regulatory requirements of veterinary medical device. How to differentiate regulations of human and veterinary medical devices, manufacturing requirements, safety standards, labelling requirements, how to draft the SOPs covering material intake, production, quality control, packing, distribution and sales.
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.Areas Covered in the Webinar:
This course is designed for individuals tasked with developing and maintaining an Animal Health company’s product portfolio that includes veterinary medical devices; and those responsible for overseeing a company’s regulatory strategies and mitigating possible FDA enforcement risk. Examples of those who may benefit include:
President, ReCellerate, Inc.
Karl Nobert is a Food and Drug Regulatory Attorney with Fuerst Ittleman David & Joseph of Miami, Florida. He is based in Washington, DC.
Mr. Nobert regularly represents clients before the Food and Drug Administration (FDA), United States Department of Agriculture (USDA) and Federal Trade Commission (FTC). Karl also represents clients in state food and drug law matters on various regulatory matters including wholesaler/distributor licensing and registration.
He focuses his practice on the representation and counseling of clients in the food and drug industry including advising clients on matters related to the regulation of human prescription and nonprescription drugs, human and veterinary biological products including regenerative medicine, medical devices, food and dietary supplements.
Karl also assists clients with the preparation of FDA submissions including human and veterinary new drug and generic drug applications; 510(k) premarket notifications, premarket approval applications, recalls and market withdrawals, GRAS self-affirmations and notifications, and product listings and establishment registrations.
Under FDCA, a “Medical Device” is defined as:
An instrument, apparatus, implement, machine, contrivance, implant, in- vitro reagent, or other similar or related article, including any component, part, or accessory thereof, which is intended for use in the diagnosis of disease or other conditions; in the cure, mitigation, treatment, or prevention of disease in man or other animals; or which is intended to affect the structure or any function of the body of man or other animals does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals, and is not dependent upon being metabolized for the achievement of any of its principal intended purposes. See FDCA Section 201(h) (emphasis added). Examples of medical devices regulated by FDA include products such as needles, syringes, surgical instruments, prosthetic devices, X-ray equipment, some injectable scaffoldings, diagnostic test kits, and dental appliances.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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