USFDA issues draft Guidance on the Acceptance of Medical Device Clinical Data

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Dear All

The US Food and Drug Administration (FDA) has published the draft version of the guidance document titled “Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States”.

The scope of guidance focuses on considerations sponsors of device submissions should take into account when initiating, or relying on previously collected data from, an OUS clinical study to support an IDE, Premarket Notification (510(k)), De Novo Petition (de novo), Humanitarian Device Exemption (HDE), or Premarket Approval Application (PMA)). This guidance also notes other important considerations to take into account when initiating or relying on OUS data.

For more details please refer the FDA link (broken link removed)
 

Attachments

  • Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States.pdf
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