Can data from studies performed outside of the United States ( U.S.) be used to support an IVD premarket submission?
Yes. FDA recognizes there may be a need to go outside of the U.S. to find adequate numbers of subjects for certain disease states, conditions, or pathogens. The PMA regulation contains information regarding research conducted outside of the U.S. (21 CFR 814.15). FDA can also accept data from foreign studies in support of 510(k)s .
Related Questions
- How much data has been used to support the clearance of the Menaflex device compared to that provided in submissions for other cleared surgical meshes?
- Can data from studies performed outside of the United States ( U.S.) be used to support an IVD premarket submission?
- Can published literature be used to support an IVD premarket submission?
