• Summary
• Background
• Meeting Materials

Summary:

On March 1, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar for industry and other interested stakeholders to discuss and answer questions about the final guidance: Principles for Selecting, Developing, Modifying and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. This guidance outlines recommended best practices to help ensure relevant, reliable, and sufficiently robust patient-reported outcome instruments are developed, modified, or adapted using the least burdensome approach.

During this webinar the FDA:

• Described key principles to consider when incorporating patient-reported outcome (PRO) instruments into the total product life cycle of medical devices;
• Described the importance of ensuring PRO instruments are fit-for-purpose; and
• Outlined best practices for selection, development, modification, and adaptation of PRO instruments.

Background: 

Understanding patients’ experiences living with their health condition and its treatment or management is useful in medical device evaluation. Patient-reported outcomes (PRO) provide information on the patient's health condition as directly reported by the patient, without outside interpretation from anyone. These outcomes are assessed using PRO instruments such as questionnaires, numeric rating scales, or diaries. PRO instruments allow for the structured collection of patient experience data. This data along with other data collected in clinical studies may be used as valid scientific evidence of safety and effectiveness of medical devices.

The FDA believes that information from PRO instruments that are relevant, reliable, and sufficiently robust can provide valuable evidence to support regulatory decision making. 

Meeting Materials:

Presentation, printable slides, and transcript are available at CDRH Learn under “Specialty Technical Topics”, sub-section “Patient Engagement”.