Introduction to Medical Device Law & Regulation: The Legal Framework for Medical Device Regulation

Whether you are a new professional in the medical device industry or a seasoned regulatory affairs or legal professional needing a refresher on current Food and Drug Administration (FDA) medical device regulatory developments, you will benefit from attending The Food and Drug Law Institute’s (FDLI) in-depth, interactive two-day course. Attendees will hear from experts who will review the essential elements of medical device regulation. Gerry Prud’homme, a partner in Hogan Lovells' Washington, D.C. office, will be speaking throughout the day on June 5, and will provide an overview of medical device law and regulation, government organizational structure, and a review of the legal basis and content of a premarket approval application.

Other topics discussed during this two-day course include:

  • Legal framework of device regulation, and FDA's organizational structure and pre-market requirements
  • Postmarket requirements, Quality System (QS) regulation, adverse event reporting, and advertising and promotion
  • Key regulations and policies and how those regulations and policies are applied
  • FDA's regulatory structure
  • Preparing a successful 510(k) submission
  • New and developing FDA policies and procedures affecting all phases of medical device regulation
  • FDA's statutory authority, and emerging issues in the ever-changing regulatory landscape

This meeting can help you and your organization understand FDA regulations, support your efforts to get products approved, and know when FDA is likely to allege violations of the law. 

If you have any questions, please email Carrie Ballew or contact her at +1 310 785 4730.

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