Medical Devices

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

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

Agenda

TimeTitleNames
8:00amFDA WelcomeWilliam Maisel, MD
8:05amRegulation of SDB DevicesEric Mann, MD, PhD
8:30amCurrent Definitions for SDBSPEAKER:
Susheel Patil, MD, PhD
9:00amPANEL 1: Defining SDB Conditions for Clinical Trials
 
MODERATOR:  Stacey Ishman, MD, MPH
PANELISTS:
Susheel Patil, MD, PhD
Barbara Phillips, MD, MSPH, FCCP
Naresh Punjabi, MD, PhD
Kathleen Yaremchuk, MD
Eric Mann, MD, PhD (FDA)
10:15amBREAK 
10:30amTechnologies for Diagnosis/Monitoring of SDBSPEAKER:
Neil Freedman, MD
11:00amPANEL 2: SDB Diagnosis and Monitoring:  Role of Polysomnography vs. Home Sleep Apnea Testing (HSAT)MODERATOR: Kathleen Yaremchuk, MD

PANELISTS:
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)
12:15pmLUNCH 
1:15pmChallenges in Clinical Trials of SDB DevicesSPEAKER:
Edward M. Weaver, MD, MPH
1:45pmPANEL 3: Clinical Trial Design Considerations for therapeutic SDB DevicesMODERATOR: Barbara Phillips, MD
PANELISTS:
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)
3:00pmBREAK 
3:15pmCDRH Efforts in the Digital Health SpaceBakul Patel, MSc, MBA
3:35pmDiscussion of Current SDB Digital Health Technologies and Future TrendsSPEAKER:
Douglas Kirsch, MD
3:55pmPanel 4: Digital Health Technologies in SDBMODERATORS: James C. Denneny III, MD
PANELISTS:
Raj C. Dedhia, MD, MS
Ofer Jacobowitz, MD, PhD, FAASM
Douglas Kirsch,MD
Craig Feied, MD, FACEP, FAAEM, FACPh
Bakul Patel, MSc, MBA (FDA)
5:10pmModerator Summaries from each Panel and Concluding RemarksModerators and FDA
5:30pmADJOURN 

Documents

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

Page Last Updated: 05/16/2018
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