Pre-Conference Primer: Fundamentals of FDA Regulatory Device Law

July 20, 2016 1:00pm

Seth A. Mailhot
Michael Best & Friedrich LLP (Washington, DC)

Aimed at providing a primer to professionals who have limited or no experience working with FDA on medical device regulatory matters, this workshop provides a basic overview of FDA device regulations and will prepare you for the more in-depth discussions that will take place throughout the conference. Topics addressed during this workshop will set the stage for the main conference by helping you thoroughly comprehend the structure of FDA and walking you through the preapproval, approval, and post-approval process. Get the background you need to flow seamlessly into the conversations at FDA Boot Camp –Devices Edition.

Topics to include:

  • Introduction to FDA: Mission and Organization
  • History of FDA Device Laws
  • Acronyms, Terminology, and Definitions
  • Basic FDA Concepts
  • The Basics of Device Classification
  • Understanding how CDER and CBER Intersect with CDRH
  • Defining the Scope of FDA’s Jurisdiction
  • Clinical Trials Process (IDEs)
  • Premarket Approval (PMA)
  • 510(k) Clearance Process
  • The Review Process
  • Labeling: Key Regulatory Requirements, Information, and Concepts
  • Post-Market Issues and Enforcement
  • Recent Developments at FDA- Regulations and Guidance, Enforcement Initiatives, Product Clearances/Approvals
  • Recalls

Resolving Ethical Challenges Encountered During the Device Approval Process

This one-hour program will explore ethical issues that may arise in the context of communications with FDA on behalf of clients. The program is based on scenarios in which FDA requires full disclosure of adverse information and authority. For example:

  • In the context of citizen petitions, FDA requires certification that the petition includes all information and views on which the petition relies as well as data and information known to the petitioner which is unfavorable to the petitioner. 21 CFR 10.30. This segment will cover the implications of that certification upon an attorney in light of Rules 1.6, 1.7, and 1.8 of the Rules of Professional Responsibility.
  • In the context of a Medical Devices Advisory Committee meeting at which counsel is present, Committee members ask whether all data regarding adverse events have been reported to FDA. This segment will cover the implications of the lawyer’s participation in light of the requirements of Rules 1.3, 3.4, and 4.1.
  • Your client has retained a former FDA official and tells you that he will be contacting FDA to discuss a pending 510(k). This segment will cover the implications of Rule 1.11.