Session (CTI)

ISSUE: In developing innovative, significant risk MDs, the need to further device design and/or functionality may require early-stage clinical investigations when non-clinical testing is either unavailable or not informative. Increased risk to patients may hamper these studies in many countries. The US FDA established an EFS Program in 2013 aimed to provide guidance, advice, and oversight to MD developers while safeguarding patients enrolled in these studies. The fragmented EU regulatory system creates challenges to conducting EFS and may hinder innovation. What can the EU and other global jurisdictions learn from the FDA experience to facilitate such studies in a safe and harmonized manner? OVERVIEW: This panel will explore lessons learned from the FDA EFS Program, examining its strengths and limitations from the perspectives of regulators, industry, and academia. Prof. Giuditta Callea (10 minutes) will moderate the session and present the rationale for EFS and their global diffusion. Ms. Dorothy Abel (15 min.) will highlight the scope, challenges, performance, and best practices developed from the first ten years of FDA EFS Program implementation. Mr. Kevin Drisko (10 min.) will offer insights into the advantages of EFS as one integrated step in the process of MD clinical evidence generation. Prof. Giuditta Callea (10 min.) will discuss the challenges of pre-market clinical research for MDs in the EU representing multi-stakeholder perspectives from patients, trialists, and hospitals and will present findings of the HEU-EFS project. In the last 15 minutes, she will direct audience questions to the panelists in a roundtable. Many stakeholders will benefit from attending this session, including regulators, healthcare providers, patient associations, academic and research organizations, CROs, ethical and legal experts, and technology developers.