FDA DRAFT GUIDANCE ON THE ACCEPTANCE OF FOREIGN CLINICAL DATA ON DEVICES

As medical device innovation continues to expand rapidly, regulators have needed to evolve strategies and issue new guidance to address the increase in global clinical studies. One such example is the recently released FDA guidance, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States, which seeks to clarify and simply the process for companies that utilize clinical data gathered outside of the US. The guidance also outlines the FDA’s criteria for accepting foreign data as part of a device premarket registration submission. Device clinical teams are keen to understand how the FDA will evaluate the data and the effects the guidance will have on clinical innovation. This program will include a review of data on recent submissions including foreign clinical data, and the impact of using foreign data on overall review times. Best practices for use of foreign clinical data will also be addressed.

• Current FDA regulations specific to the acceptance of foreign clinical data
• Considerations pertaining to foreign studies: Ensuring standards are met
  • Clinical conditions
  • Study populations
  • Regulatory requirements
• Draft guidance pros and cons for industry manufacturers

Speaker:
Janice M. Hogan
Managing Partner
Hogan Lovells

Contact:

Brooke Akins | Manager, Market Intelligence | 312.224.1693 webinars@q1productions.com