Set to release Tuesday, April 28, FDA plans to issue a draft guidance document regarding its current policy of accepting clinical trial data performed outside the United States in support of medical device premarket submissions. To be clear, this document is not intended to announce a new policy, but rather articulate specific measures and considerations that must be applied when using such data to ensure the foreign medical device clinical data is adequate under FDA standards.
Such medical device manufacturers planning on submitting clinical data from outside the United States much provide the following information:
- Detailed information about the research facilities and qualifications of the trial’s clinical investigators
- Protocol and results summary
- Full description of the device
- Demonstration of the scientific validity for all of the gathered data
- Ample assurances concerning informed consent
Ultimately, this guide document could provide clarity, help ensure the data is compliant with FDA standards, and allow products to reach the global market sooner.
To learn more, read Outsourcing-Pharma’s article by Zachary Brennan.