FDA Draft Guidance on the Acceptance of Foreign Clinical Data on Devices

1 Hour Video | Janice M. Hogan, Hogan Lovells

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  • Draft guidance pros and cons for industry manufacturers

 

Participants that will find this webinar most beneficial will be those involved in medical device companies.  Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Clinical Affairs
  • Legal Counsel

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Janice M. Hogan
Managing Partner
Hogan Lovells

Janice Hogan is the Managing Partner of Hogan Lovells’ Philadelphia office and is Co-Director of our FDA/Medical Device practice. Janice focuses her practice primarily on the representation of medical device, pharmaceutical, and biological product manufacturers before the U.S. Food and Drug Administration (FDA).

Janice is a biomedical engineer and focuses on regulatory counseling related to high technology medical products. Prior to becoming an attorney, she held positions in marketing/marketing research for a major pharmaceutical manufacturer. She has authored articles regarding the medical device 510(k) review process, regulation of medical software, orphan drug regulation and medical device products liability. She is currently authoring articles regarding the use of finite element analysis and other engineering modeling methods in FDA submissions, as well as the interface between FDA regulatory and reimbursement considerations in the design of medical product clinical trials.


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