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
These valuable takeaways will be provided onsite:
- A binder of speaker handouts and related reference materials
- Access to an electronic copy of the FDCA Statutory Supplement, 2021 2nd Edition
Who Should Attend
- New legal and regulatory professionals
- Seasoned practitioners new to the topic or wanting a refresher