Updates for 2021
FDLI remains committed to providing high-quality educational programs while keeping our members and event attendees safe during the current pandemic. With this in mind, we are excited to announce that the 2021 Introduction to Medical Device Law and Regulation Course will be a completely virtual event. Please know we are actively exploring options to ensure an engaging and enjoyable experience. Be sure to check the course website regularly for additional announcements and updates.
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:
- 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
Register by November 5 and SAVE!
Industry & Firms
- +$400 for non-members
- +$100 after 11/5/21
Non-Profit
- +$200 for non-members
- +$100 after 11/5/21
Government
- +$200 for non-members
- +$100 after 11/5/21
Academic
- +$200 for non-members
- +$100 after 11/5/21
Internet Explorer and Microsoft Edge are not supported by the checkout process.
Please use Chrome, Firefox, or Safari. If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.
Add This Must-Have Reference to Your Registration
Purchase A Practical Guide to FDA’s Food and Drug Law and 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.
You can transfer your registration to another person at your organization for no cost by notifying us of the change. If you notify FDLI in writing at least five business days prior to the meeting, you can cancel your registration for a full refund (less a $75 fee). Refunds will be applied against the original form of payment.
Our event policies are listed here. If you should have any further questions, please contact us at [email protected] or 800-956-6293.
Agenda
subject to change
All times are in Eastern Time
Curriculum Advisor:
Janice M. Hogan, Partner, Hogan Lovells US LLP
Tuesday, November 16
12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
12:05–1:05 PM
Overview of Medical Device Law and Regulation and Organizational Structures
Justine E. Lenehan, Associate, Kleinfeld, Kaplan, & Becker, LLP
1:05–1:15 PM
Break
1:15–2:30 PM
Premarket Notification 510(k) and De Novo Requests
Ryan M. Fournier, Partner, Wiley
2:30–2:40 PM
Break
2:40–3:40 PM
Registration and Listing
Abeba Habtemariam, Counsel, Arnold & Porter LLP
3:40–3:50 PM
Break
3:50–5:00 PM
Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRBs), and informed Consent
Blake E. Wilson, Senior Associate, Hogan Lovells US LLP
Wednesday, November 17
12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
12:05–1:05 PM
Clinical Investigations: Sponsor/Investigator Responsibilities and Compliance Issues
Rebecca Jones McKnight, Partner, DLA Piper LLP (US)
1:05–1:15 PM
Break
1:15–2:15 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE)
Kristin M. Zielinski Duggan, Partner, Hogan Lovells US LLP
2:15–2:30 PM
Break
2:30–3:30 PM
Coverage, Coding and Payment – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)
Michael M. Gaba, Shareholder, Polsinelli PC
3:30–3:45 PM
Break
3:45–5:00 PM
Post Marketing Issues
Thursday, November 18
12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
12:05–1:05 PM
Enforcement and Compliance
Gregory H. Levine, Partner, Ropes & Gray LLP
Beth P. Weinman, Counsel, Ropes & Gray LLP
1:05–1:15 PM
Break
1:15–2:35 PM
Promotion and Advertising
James R. Ravitz, Partner, Wilson Sonsini Goodrich & Rosati
Georgia C. Ravitz, Partner, Wilson Sonsini Goodrich & Rosati
2:35–2:50 PM
Networking and Refreshment Break
2:50–3:50 PM
Manufacturing and Quality System (QS) Regulation
Elaine H. Tseng, Partner, King & Spalding LLP
3:50–4:00 PM
Break
4:00–5:00 PM
International Issues
John F. Johnson, III, Of Counsel, Shook, Hardy & Bacon LLP
5:00 PM
Adjournment
Continuing Legal Education
FDLI applies for CLE credits in Ohio and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.