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  5. Public Workshop - Study Design Considerations for Devices Including Digital Health Technologies for Sleep Disordered Breathing in Adults, April 16, 2018 - 04/16/2018 - 04/16/2018
  1. Workshops & Conferences (Medical Devices)


Event Title
Public Workshop - Study Design Considerations for Devices Including Digital Health Technologies for Sleep Disordered Breathing in Adults, April 16, 2018
April 16, 2018

April 16, 2018
4:00 AM - 1:30 PM ET

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Study Design Considerations for Devices including Digital Health Technologies for Sleep Disordered Breathing in Adults.” The topic to be discussed is the appropriate design of clinical studies to evaluate devices including digital health technologies intended for the diagnosis, monitoring, or treatment of Sleep Disordered Breathing (SDB) in adults. Study design considerations to be discussed include definitions for SDB conditions, inclusion/exclusion criteria for studies of these conditions, use of SDB assessment technologies, controls, and study endpoints.

Date, Time and Location

This meeting will be held April 16, 2018, beginning at 8:00 a.m. – 5:30 p.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed.

Webcast Archive


Time Title Names
8:00am FDA Welcome William Maisel, MD
8:05am Regulation of SDB Devices Eric Mann, MD, PhD
8:30am Current Definitions for SDB SPEAKER:
Susheel Patil, MD, PhD
9:00am PANEL 1: Defining SDB Conditions for Clinical Trials
MODERATOR:  Stacey Ishman, MD, MPH
Susheel Patil, MD, PhD
Barbara Phillips, MD, MSPH, FCCP
Naresh Punjabi, MD, PhD
Kathleen Yaremchuk, MD
Eric Mann, MD, PhD (FDA)
10:15am BREAK  
10:30am Technologies for Diagnosis/Monitoring of SDB SPEAKER:
Neil Freedman, MD
11:00am PANEL 2: SDB Diagnosis and Monitoring:  Role of Polysomnography vs. Home Sleep Apnea Testing (HSAT) MODERATOR: Kathleen Yaremchuk, MD

Neil Freedman, MD
Charlene Gamaldo, MD, FAAN
Boyd Gillespie, MD, MSc, FACS
Ilene Rosen, MD, M.S.C.E.
Jessica Schmidt, FACHE, MA, RPSGT, CCSH
James Lee, PhD (FDA)
12:15pm LUNCH  
1:15pm Challenges in Clinical Trials of SDB Devices SPEAKER:
Edward M. Weaver, MD, MPH
1:45pm PANEL 3: Clinical Trial Design Considerations for therapeutic SDB Devices MODERATOR: Barbara Phillips, MD
Shahrokh Javaheri, MD
Naresh Punjabi, MD, PhD
Edward M. Weaver, MD, MPH
Kathleen Yaremchuk, MD
Will Headapohl, MS (patient rep)
Gail Demko, DMD
Anne E. O'Donnell MD
Srinivas Nandkumar, PhD (FDA)
3:00pm BREAK  
3:15pm CDRH Efforts in the Digital Health Space Bakul Patel, MSc, MBA
3:35pm Discussion of Current SDB Digital Health Technologies and Future Trends SPEAKER:
Douglas Kirsch, MD
3:55pm Panel 4: Digital Health Technologies in SDB MODERATORS: James C. Denneny III, MD
Raj C. Dedhia, MD, MS
Ofer Jacobowitz, MD, PhD, FAASM
Douglas Kirsch,MD
Craig Feied, MD, FACEP, FAAEM, FACPh
Bakul Patel, MSc, MBA (FDA)
5:10pm Moderator Summaries from each Panel and Concluding Remarks Moderators and FDA
5:30pm ADJOURN  


Registration to Attend the Workshop

As of April 9, online registration is closed. On-site registration will be available the morning of the workshop.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communications and Education Programs, 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.

For questions regarding workshop content please contact:

Sageev George, PhD
Food and Drug Administration,
Center for Devices and Radiological Health,
10903 New Hampshire Ave., Bldg. 62 rm. 2443, Silver Spring, MD 20993-0002,
Tele: 301-796-6468,
Email: sageev.george@fda.hhs.gov

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