FDA issues final rule on international study data: 3 things to know

Written by Shayna Korol | February 21, 2018 | Print  |

The FDA is requiring that data submitted from clinical investigations conducted outside the U.S. for medical device approval be conducted according to good clinical practice. This final rule is effective Feb. 21, 2019.

Here are three things to know:


1. The rule applies to data submitted from clinical investigations conducted outside the U.S. intended to support an application for:

  • An investigational device exemption
  • Premarket notification  submission
  • De Novo classification request
  • Premarket approval
  • Product development protocol
  • A humanitarian device exemption


2. Good clinical practice includes obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee, along with obtaining and documenting freely given informed consent of subjects.


3.The final rule aims to provide consistency in FDA requirements for acceptance of data from clinical investigations regardless of application or submission type. It also intends to help ensure the quality and integrity of data obtained from these investigations and human subject protection.


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