- Digital Health Technologies (DHTs)
- Digital Biomarkers, Clinical Outcome Assessments (COAs)
- Patient-Reported Outcomes (PROs)
- Performance Outcomes (PerfOs)
- Observer-Reported Outcomes (ObsROs)
- Patient Preference Information (PPI)
January 26, 2022
10:30 a.m. to 3:30 p.m. ET
Location: Interactive Online Course, delivered virtually by FDA Staff
Are you a digital health innovator? Are you building sensors, wearables, or other digital health tools to be used in clinical trials to capture information about how patients feel, function, or survive?
Join the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), the University of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI) and the Johns Hopkins University CERSI for an immersive mini-bootcamp, being held virtually and in a condensed format due to the COVID-19 pandemic.
Be empowered to navigate the Digital Health Technology development and evaluation journey from patient needs assessment, to product development and validation tailored to supporting the context of use, to measuring patient outcomes and preferences.
The hands-on training will provide an opportunity for early-stage innovators to:
- Become fluent with terminology and aware of regulatory considerations and resources.
- Have more informed interactions with regulators.
- Improve their evidence generation.
- Bring safe and effective medical technologies into the healthcare system in a timely manner.
The emphasis of this bootcamp will be on Digital Health Technologies used to facilitate assessment of patient outcomes in clinical trials (i.e., Clinical Outcome Assessments (COAs)).
- Develop high-level understanding of the regulation of medical devices and use vocabulary used by FDA when communicating about patient outcome measurements and DHTs.
- Describe important considerations for development, validation, and use of DHTs and outcome measurement tools for regulatory purposes.
- Differentiate between PPI and PROs, and describe how PPI can inform on unmet needs and tool development.
- Develop practical expertise applying bootcamp concepts to cases relevant as an innovator developing and bringing medical technologies to the market.
This is an invitation-only event. Participants are required to complete an initial interest form and will be notified if they are selected and invited to register for attendance. There is no registration fee.
The completed interest form was due for submission on 12/2, 11:59 PM ET.
Selected participants are required to complete approximately one hour of pre-bootcamp activities on their own in advance of the live event.
This event is brought to you by the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), the University of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI), and the Johns Hopkins University CERSI.
This event is also being advertised by Johns Hopkins University CERSI. Please note, if you received an email or link to an event landing page hosted by JHU, the event information – and interest form submission link – is the same across both platforms.
This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.