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Meeting | Virtual

Event Title
Virtual Public Meeting – Food and Drug Administration, Center for Devices and Radiological Health Real-World Evidence Update
January 30, 2025

Date:
January 30, 2025
Time:
11:00 a.m. - 12:00 p.m. ET

Summary

The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) is announcing a virtual public meeting entitled “FDA/CDRH Real-World Evidence Program Update.” The purpose of this meeting is, in part, to fulfill the Center’s Medical Device User Fee Amendments 2022 (MDUFA V) commitment to update the public on the CDRH’s Real-World Evidence (RWE) program activities.

Background

Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources such as digital health technologies that can inform on health status. The RWE is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.

As part of CDRH’s MDUFA V commitments, the Center continues to develop RWD and RWE methods and policies to advance regulatory acceptance for premarket submissions, including expanded indications for use and clearance/approval of new devices. The meeting will be a public forum for CDRH to share recent RWE program updates and engage with the public on RWD and RWE.

Date and Time

This public meeting will be held on January 30, 2025, from 11 a.m. to12 p.m. by webcast.

Webcast

The public meeting will be webcasted, and if you register, the link will be provided in your confirmation email. The link for the archived webcast will be posted to the webpage for viewing after the meeting.

Agenda

The following public meeting agenda is preliminary and subject to change.

TimeSubjectName of Speaker
11 a.m. – 12 p.m.

Update on RWE Program Activities:

  • Training
  • Overview of the CDRH Draft RWE Guidance issued December 2023
  • Case Examples
  • National Evaluation System for Health Technologies (NEST)
  • Q & A
Hajira Ahmad 
Felipe Aguel

Registration

If you wish to attend this meeting, you must register by 4:00 p.m. on January 29, 2025, at https://www.surveymonkey.com/r/RealWorldEvidenceUpdate. There is no fee to register for this meeting. When registering, you will be asked to provide the following information:

  1. Name
  2. Affiliation, Company or Organization
  3. E-mail address
  4. Interested Party Category (Academia, Clinician, Consultant, Government, Industry, Regulatory and Other)

Registrants will receive confirmation when requests for registration have been processed. If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661. Susan.Monahan@fda.hhs.gov.

Comments

Please submit your comments regarding the workshop to https://www.regulations.gov/, Docket No. FDA-2024-N-5760 by 3/3/2025.

Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is received.

Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at http://www.regulations.gov.

Contact

For questions regarding meeting content please contact:

Jayna Wiebel
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993
Email: CDRHClinicalEvidence@fda.hhs.gov

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