Regulatory News

CDRH Sees Spike in Pre-Market Submissions With Patient-Reported Outcome Measures

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday issued its first report on patient-reported outcomes (PROs), noting a significant uptick in PRO data submitted in 2017.

Over a six-year period, the report says CDRH observed a more than 500% increase in the number of pre-market submissions that include PRO measures.

And in FY 2017, more than 75% of approved, pivotal original and new study investigational device exemptions (IDEs) submitted to the Office of Device Evaluation (ODE) included a PRO measure within the submission.

"The significant increase in the number of product applications submitted with patient perspective information shows that manufacturers, like the FDA, recognize the value of this information," CDRH Director Jeff Shuren said in a statement.

But the use of PROs in post-approval studies (PAS) has fluctuated, from six of 19 (32%) studies including a PRO in 2015, to four of 16 (25%) including a PRO in 2016 to three in 10 (30%) studies including a PRO in 2017, the report finds.

"Assessing trends on the use of PROs in postmarket mandated studies is challenging because the numbers are driven by the questions that need to be addressed," the report says.

The report also features examples of using PROs as patient priority measures, in clinical care, as safety endpoints and as a customizable measure specific to a treatment area and/or specific device.

Moving forward, CDRH says it will develop a "fit-for-purpose" framework for assessing validation evidence for PROs and a template for sponsors choosing to perform a bridging study to develop or modify a PRO to facilitate their conduct and reporting of a study.

Value and Use of Patient-Reported Outcomes (PROs) in Assessing Effects of Medical Devices