FDA has released a draft guidance to further explain how the agency considers real-world data in making premarket and postmarket regulatory decisions. The draft, Use of Real World Evidence to Support Regulatory Decision-Making for Medical Devices, also explains when an investigational device exemption might be necessary to collect and use such data to determine device safety and effectiveness.
“Real-world data, which are collected from sources outside of traditional clinical trials, can provide powerful insight into the benefits and risks of medical devices, including how they are used by health care providers and patients,” according to an FDA announcement. ”This draft guidance is a cornerstone of our strategic priority of creating a national evaluation system for medical devices. That system would build on and leverage the vast amount of data and information collected during the treatment and management of patients.”
There is a 90-day comment period for the draft guidance.