Veterinary Medical Devices and FDA’s Regulatory Oversight

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.

Areas Covered in the Webinar:

• Understand how the U.S. FDA regulates veterinary medical devices
• Be able to confidently discuss the regulatory requirements for marketing and selling a veterinary medical device in the U.S.
• Identify the similarities and differences between the regulation of human and veterinary medical devices
• Be capable of distinguishing between veterinary medical devices and other animal health products through reliance on the human medical device market
• Develop a working knowledge of the manufacturing requirements applicable to these products
• Learn the Safety Standard applicable to a device
• Be able to properly label a veterinary medical device so that it complies with FDA’s regulatory requirements
• Gain exposure to the Consumer Products Safety Commission (“CPSC”) and the Federal Trade Commission (“FTC”) that may be involved in the jurisdiction of these products
• Be able to discuss how the National Advertising Division (“NDA”) may impact the marketing and sale of these products
• Be in a position to design and draft Standard Operating Procedures (“SOPs”) covering the material intake, production, quality control, packaging, distribution and sale of such devices, and
• Have the knowledge to draft an SOP covering marketing and promotion.

Who Will Benefit:

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:

• Division Directors and Chiefs
• Business Development Team Members
• Senior Quality Managers
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Labelers and Private Labelers
• Contract Manufacturers
• Importers and Custom Agents
• U.S. Agents of Foreign Corporations
• Legal Professionals
• Financial Advisors and Institutional Investors
• Consultants, Inspectors and Manufacturing Experts

Karl M. Nobert
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.

Veterinary Medical Device:

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.

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