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  5. Webinar - Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation - Final Guidance - 03/01/2022
  1. Workshops & Conferences (Medical Devices)

Webcast

Event Title
Webinar - Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation - Final Guidance
March 1, 2022

Date:
March 1, 2022
Time:
1:00 PM - 2:30 PM ET

Summary: 

The U.S. Food and Drug Administration (FDA) will host 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.

This webinar will:

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

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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. 

Webinar Details:

Registration is not necessary.

Date: March 1, 2022
Time: 1:00 PM - 2:30 PM ET

To ensure you are connected, please dial-in 15 minutes before the start of the webinar.

Please click the button below to join the webinar: 

Please note: Participants who join using the Zoom webinar link above should use computer audio (listen through their computer speakers and speaking through computer microphone/headset).

The dial-in information provided below is for participants who will be joining by phone only.

To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join.php?i=PW3574016&p=7702741&t=c

After the webinar, a transcript, recording, and slides will be posted below.


Note: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance for webinar attendance.

Target Audiences: Industry (medical device companies or distributors, technology manufacturers (including start-up companies or labs), academic and research institutions, professional societies, patient organizations, foundations and other non profit organizations.

If you have any questions about this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at [email protected], 1-800-638-2041, or 301-796-7100.

Food and Drug Administration Center for Devices and Radiological Health

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