The US FDA will no longer require that identifiable individual patient data be required from applicants when submitting real-world evidence as part of certain medical device applications.
Sponsors have been clamoring for the change for some time as the individual patient data requirement was seen as burdensome and unnecessary.
The agency said the move means that “meaningful information can be extracted from some big data sources without private, individual information.”
Since 2016, the FDA said more than 250 premarket authorizations for medical devices included real-world evidence.
The agency added it is considering the same change for drugs and biologics applications.
