Introduction to Medical Device Law and Regulation

April 9–10, 2024   Washington, DC   In-Person Course

Overview

Explore the essentials of device law and regulation and gain a comprehensive understanding of the administrative agencies that impact this industry. Learn about registration and listing procedures, elements of conducting clinical investigations, Premarket Approval Application, advertising and promotion, compliance, enforcement, and related issues. Case studies, hypotheticals, and ample time for Q&A are provided.

Agenda Highlights

  • Overview of the organizational structure of the FDA
  • FDA’s regulatory process for medical devices
  • How to prepare a successful 510(k) submission
  • Registration and listing requirements
  • Elements of conducting clinical investigations
  • Premarket Approval Application (PMA) and approval process
  • Post-marketing requirements
  • FDA’s enforcement tools and procedures
  • Advertising and promotion requirements
  • Quality System Regulation (QSR)

Statutes Covered

  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • 1976 Medical Device Amendment
  • Safe Medical Devices Act of 1990 (SMDA)
  • Mammography Quality Standard Act of 1992 (MQSA)
  • Food and Drug Administration Modernization Act of 1997 (FADAMA)
  • Food and Drug Administration Amendments Act of 2007 (FDAAA)
  • 21st Century Cures Act (2016)
  • Medical Device User Fee Reauthorization Legislation (including Food and Drug Administration Reauthorization Act of 2017 (FDARA))

Attendee Resources

Who Should Attend

  • New legal and regulatory professionals
  • Seasoned practitioners new to the topic or wanting a refresher

Register

Early registration expires 3/1/2024

 

$1299

Members

$1699

Non-members

Industry

$1299

Members

$1699

Non-members

Government
& Association

$899

Members

$1099

Non-members

Public/Patient Org
& Academic

$1099

Members

$1299

Non-members

Student

FREE

Members

$1299

Non-members

Add This Must-Have Reference to Your Registration Purchase

Purchase A Practical Guide to FDA’s Food and Drug Law Regulation, 7th Edition to have an overview of the key legal and regulatory topics at your fingertips.  Order your copy today and it will be shipped directly to your office.

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