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Medical Device Clinical Study Requirements: New Changes Proposed by FDA for Foreign & U.S. Studies
Medical Device Clinical Study Requirements: New Changes Proposed by FDA for Foreign & U.S. Studies

Our Price: $395.00

Product Code: WB-7024

Product Info

About the Product
Includes 1 hour and 30 minute Windows Media Video File and PowerPoint presentations for immediate download.

The medical device industry has recently seen a spike in companies conducting clinical studies outside the US (OUS) due to limitations in time, money, and other resources, combined with stringent FDA guidelines for US studies. However, FDA’s device regulations largely do not address or clarify requirements for assuring the acceptability of data from OUS studies to support US research or marketing applications. Additionally, there are inconsistencies in FDA’s device regulations regarding information to be provided about US clinical studies in different types of FDA applications. To address these issues and better harmonize regulatory expectations for clinical studies, whether conducted inside or outside the US, and whether used to support a FDA premarket approval application (PMA), premarket notification (510(k)), or investigational device exemption (IDE) submission, FDA recently issued a proposed rule -open for comment until May 28, 2013 - that would amend various parts of its device regulations. If finalized, these proposed amendments will significantly alter what companies must do to successfully use data generated abroad in support of FDA applications and submissions; it will also have new impacts for companies submitting US clinical data in support of FDA submissions.

  • FDA’s proposed requirement that clinical studies conducted outside the US be compliant with good
  • clinical practices (GCP), including how FDA proposes to define GCP
  • What companies would need to do to demonstrate GCP compliance when seeking to rely on foreign
  • data in FDA submissions, including 510(k)s and IDEs
  • The proposed rule’s implications for US-based clinical data submitted in FDA applications
  • Practical considerations and strategies in light of the proposed rule


Elaine H. Tseng
King & Spalding LLP

Target Audience

  • Clinical Coordinator
  • Regulatory Affairs
  • GCP Compliance

Target Industry

  • Medical Device Companies
  • Clinical Affairs and Operations

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