New FDA Guidance on Device Data from Foreign Studies
The U.S. Food and Drug Administration has issued draft guidance on the agency’s current policy of accepting scientifically valid clinical data obtained from foreign clinical studies in support of premarket submissions for medical devices.
The U.S. Food and Drug Administration has issued draft guidance on the agency's current policy of accepting scientifically valid clinical data obtained from foreign clinical studies in support of premarket submissions for medical devices.
The draft guidance describes special considerations that apply when using such data, including applicability to populations within the U.S., to ensure data are adequate under applicable FDA standards.
Also See: FDA Program Fast-Tracks Devices for Unmet Medical Needs
The draft guidance is not intended to announce new policy, but to describe FDAs existing approach to this topic, states an April 21 Federal Register notice. The draft guidance, when finalized, will represent the agencys current thinking on acceptance of clinical data from foreign studies.
The 2012 FDA Safety and Innovation Act affirmed FDAs longstanding policy of accepting adequate, ethically-derived, scientifically valid data without regard to where a clinical study is conducted. However, there are challenges in using data derived from studies of devices from sites outside the U.S. (OUS) to support an FDA marketing decision. According to the regulatory agency, these challenges may include differences between the OUS and U.S. clinical conditions, regulatory requirements (including human subject protections), and/or study populations that may be sufficient to affect the adequacy of the data.
The FDAs draft guidance focuses on considerations sponsors of device submissions should take into account when initiating, or relying on previously collected data from an OUS clinical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 Investigational Device Exemption, Premarket Notification (510(k)), De Novo Petition, Humanitarian Device Exemption, or Premarket Approval Application.
The draft guidance describes special considerations that apply when using such data, including applicability to populations within the U.S., to ensure data are adequate under applicable FDA standards.
Also See: FDA Program Fast-Tracks Devices for Unmet Medical Needs
The draft guidance is not intended to announce new policy, but to describe FDAs existing approach to this topic, states an April 21 Federal Register notice. The draft guidance, when finalized, will represent the agencys current thinking on acceptance of clinical data from foreign studies.
The 2012 FDA Safety and Innovation Act affirmed FDAs longstanding policy of accepting adequate, ethically-derived, scientifically valid data without regard to where a clinical study is conducted. However, there are challenges in using data derived from studies of devices from sites outside the U.S. (OUS) to support an FDA marketing decision. According to the regulatory agency, these challenges may include differences between the OUS and U.S. clinical conditions, regulatory requirements (including human subject protections), and/or study populations that may be sufficient to affect the adequacy of the data.
The FDAs draft 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 Investigational Device Exemption, Premarket Notification (510(k)), De Novo Petition, Humanitarian Device Exemption, or Premarket Approval Application.
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