3-hr Virtual Seminar: FDA Medical Device Regulation for the Beginner

Why Should You Attend:

This webinar is intended to provide the Beginner with an introduction to the U.S. Food and Drug Administration’s regulation of medical devices.

This introductory course will present the beginner with an introduction to FDA and its regulatory authority as it relates to medical devices. The presenter will discuss FDA’s medical device classification system and provide instruction on how to classify a particular medical device for regulatory purposes. The process for going to market with a Class I, Class II and Class III device will be described with particular attention being paid to the preparation and submission of 510(k)s and PMAs. An overview of a medical device manufacturer’s and/or distributor’s regulatory responsibilities will be discussed, as will issues related to FDA’s requirements governing medical device manufacturing, labeling and user fees. Next, the instructor will discuss strategies for preparing for and surviving an FDA on-site inspection. Finally, an overview of FDA medical device-focused enforcement activities and methods for mitigating enforcement risks will be provided.

Learning Objectives:

• Gain a basic understanding of FDA's structure and regulatory authority through an understanding of its laws and regulations applicable to medical devices.
• Develop a familiarity with FDA's Medical Device Classification System and learn the difference between Class I, Class II and Class III medical devices.
• Understand the difference between a 510(k) and a PMA, and when each is required.
• Learn what is included in a 510(k), how to prepare a 510(k) and the process for selecting a predicate device.
• Develop a basic understanding of FDA's Quality System Regulation (21 CFR Part 820).
• Learn what is involved in an FDA inspection, how to prepare for an FDA inspection and strategies for undergoing a successful inspection.
• Become familiar with FDA's various enforcement options as they relate to medical device marketing and sales.

Areas Covered in the Seminar:

• Organizational Structure.
• Statutory and Regulatory Authority.
• Medical Device Classification System.
• Class I Medical Devices, 510(k) Premarket Notification and Premarket Approval.
• The Process for Bringing a Medical Device to Market in the U.S.
• The Components of a  510(k) Premarket Notification.
• A Manufacturer's Responsibilities.
• User Fees.
• Labeling and Promotion.
• An Introduction to the Quality System Regulation (21 CFR Part 820).
• The Import / Export of Medical Devices.
• Inspections.
• FDA Enforcement Activities.

Who will benefit:

• Regulatory Affairs Professionals
• Managers
• Consultants
• Scientists
• Research Analysts
• State Policy Officials
• Insurers focusing on Representations & Warranties Insurance
• Investment Analysts and Venture Capitalists
• Medical Device and Biotech Companies, Start-ups, Foreign Manufacturers, Importers, Labelers, Pharmacists, Convenience Kit Manufacturers
• Financial analysts and investors watching the life sciences industries

Instructor Profile:

Karl Nobert, is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. He provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration’s review and approval of new drug products. This includes counseling clients on FDA’s regulation of prescription branded and generic drugs, and over-the-counter drug products. He also has considerable experience related to the regulation of biologics including cellular and genetic therapies, and veterinary drug products. He frequently presents and has published on such topics.

Topic Background:

The FDA regulates medical devices marketed and sold in the U.S. on the basis of potential risk and according to a 3 category classification system. Class I medical devices are deemed low risk and possess the lowest regulatory threshold for entry into the market. Class II medical devices are deemed to pose an intermediate risk to the user and require the submission of a 510(k) Premarket Notification establishing substantial equivalence to a selected predicate device. Finally, Class III devices are considered novel and unique, and/or deemed high level requiring Premarket Approval prior to marketing and sale.

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