Today the FDA released a draft guidance that could give manufacturers more direction on how they can use clinical data from studies conducted outside of the United States to support device submissions.
It is worth noting that this is not a new FDA policy. The agency is simply proving more insight on the issue.
Once final, the guidance will offer the following:
- FDA’s policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices
- The special considerations that apply when using OUS data, including applicability of the data to intended patient populations within the United States and study design issues,
- Recommendations to assist sponsors in developing data that meet FDA standards to support approval of clearance of the device in the U.S.
The comment period for the draft, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States (OUS), is open for the next 90 days.