ComplianceOnline

Veterinary Medical Devices and FDA Regulatory Oversight

Instructor: Karl M. Nobert
Product ID: 703769
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Fax: +1-650-963-2556

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Read Frequently Asked Questions

This course will discuss the regulatory requirements for marketing and selling veterinary medical devices in the U.S. Attendees will learn how to adhere to the safety standard applicable to a device and how to appropriately label a veterinary medical device to comply with FDA requirements.

Why Should You Attend:

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (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 will provide insights on how the market may develop in the future. Further, It will help attendees identify the similarities and differences between the regulation of human and veterinary medical devices .

Areas Covered in the Webinar:

  • Understand how the U.S. FDA regulates veterinary medical devices
  • Discuss the regulatory requirements for marketing and selling veterinary medical devices in the U.S.
  • Identify the similarities and differences between the regulation of human and veterinary medical devices
  • Distinguish 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
  • Learn how 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
  • Discuss how the National Advertising Division (NDA) may impact the marketing and sale of these products
  • Learn to design and draft Standard Operating Procedures (SOPs) covering the material intake, production, quality control, packaging, distribution and sale of such devices
  • Best practices 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. This includes:

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

Instructor Profile:

Karl M. Nobert 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. Mr. Nobert 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.

He represents clients before the Food and Drug Administration (FDA), the United States Department of Agriculture (USDA) and Federal Trade Commission (FTC). Mr. Nobert also represents clients in state food and drug law matters on various regulatory matters including wholesaler/distributor licensing and registration.

He currently serves as legal advisor to the International Veterinary Regenerative Medicine Society (IVRMS) and is a member of the National Thoroughbred Racing Association’s (NTRA) Safety and Integrity Alliance Subcommittee on Aftercare. He is also the author of numerous articles and frequently presents on various FDA regulatory topics.

Topic Background:

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) 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. This is intended to protect both the nation’s animal and human populations from the detrimental impact of unsafe and dangerous medical device products.

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