Workshop B – Resolving Ethical Challenges Encountered during the Device B Approval Process

Jul 26, 2017 4:15pm – 5:15pm

Sonali P. Gunawardhana
Of Counsel
Wiley Rein LLP (Washington, DC)

Sally L. Maher
VP Regulatory Affairs
Edwards Life Sciences (Irvine, CA)

This one-hour ethics session will cover common ethical issues that arise while communicating with FDA during the approval process. The session will address various scenarios that raise questions on the extent of disclosure of adverse information such as:  
  • Scenario 1: 21 C.F.R. 10.30 requires a petitioner to certify that a citizen 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. This session will address the implications of this certification on an attorney in light of Rules 1.6, 1.7, and 1.8 of the Rules of Professional Responsibility.
  • Scenario 2: 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.
  • Hypothetical: 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.