ADVOCATE. CONNECT. INNOVATE.

Introduction to US Medical Device Law and Regulation

South San Francisco, CA

7/26/2018 - 7/27/2018

8:00am

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)
  • Radiation Control for Health and Safety Act of 1968 (RCHSA)
  • 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)
  • Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
  • Food and Drug Administration Amendments Act of 2007 (FDAAA)

Attendee Resources

These valuable takeaways will be provided onsite:

Who Should Attend

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Contact: Food and Drug Law Institute
Contact Email: info@fdli.org

Event Address:

California Life Sciences Association Event Center
701 Gateway Blvd, Suite 440
South San Francisco, CA 94080