The FDA may start accepting real-world evidence in support of device applications, but sponsors need to identify the sources of real-world evidence they’re using in advance, the agency said.
Sponsors should say in their cover letters whether they hope to use real-world evidence to support safety or efficacy, to change a label, or to comply with a post-marketing requirement, the FDA said in a new draft guidance.
The guidance draws a line between real-world data—information about patients’ health status or healthcare delivery “routinely collected from a variety of sources,” including electronic health records, medical claims or billing data—and clinical evidence from analysis of real-world data.
