The FDA Issues Draft Guidance on Patient-Reported Outcome Instruments for Medical Devices and Reminds Public of Upcoming Virtual Meetings

Today, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance on Patient-Reported Outcomes and is reminding the public of two upcoming virtual meetings on Patient Preference Information (PPI) and Patient-Reported Outcomes (PRO).

Draft Guidance

The FDA issued a draft guidance, Principles for Selecting, Developing, Modifying and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. This draft provides the FDA’s current thinking about the best practices for incorporating patient-reported outcome (PRO) instruments throughout the lifecycle of a medical device.

This draft guidance, when finalized, is intended to:

Outline qualities of PRO instruments that are relevant, reliable, and sufficiently robust to capture outcomes of importance to patients, regulators, and others in the health care community.
Provide recommendations for less burdensome ways to develop PRO instruments including using or modifying existing well-defined and reliable instruments for new contexts of use.

This draft guidance will be open for public comments for 60 days at Regulations.gov under docket number FDA-2020-D-1564.

Read the Draft Guidance

Reminder: Upcoming Virtual Meetings

The FDA will be hosting two upcoming virtual meetings about patient-preference information (PPI) and patient-reported outcomes (PRO). Registration for both meetings is currently open and there are no fees to register.

ISPOR-FDA Summit 2020: Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond
Workshop Date: Tuesday, September 29, 2020, 10:30 AM – 4:45 PM, EDT
Register here
Patient-Reported Outcomes (PROs) and Medical Device Evaluation: From Conception to Implementation
Workshop Date: Wednesday, September 30, 2020, 10:00 AM – 4:00 PM, EDT
Register here