The U.S. Food and Drug Administration (FDA) has released its first report on patient-reported outcomes (PROs) from the use of medical devices.
Patient-reported outcomes data can include information such as how a patient functions with a new orthopedic device, how a device affects a patient's quality of life, or whether a device affects a patient's symptoms. The FDA has seen the amount of PRO data it receives increase significantly in recent years; in 2017, more than 80% of investigational device exemptions (IDEs) included patient outcomes data.
In a December 12 report released by the FDA's Center for Devices and Radiological Health (CDRH), the agency outlined the steps it is taking to meet the increase in PRO data, as well as the training and education FDA staff members are receiving in handling the data. The FDA continues to encourage device makers to include PRO data with their regulatory submissions.
The report can be viewed on the agency's website.
