Public
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
- Date:
- April 16, 2018
- Time:
-
04:00 AM - 01:30 PM EDT
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
- Federal Register Notice
- Webcast Archive
- Agenda
- Documents (Bios, Questions)
- Registration
- Contact Us
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
| 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 PANELISTS: 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 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) |
| 12:15pm | 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 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) |
| 3:00pm | 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 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) |
| 5:10pm | Moderator Summaries from each Panel and Concluding Remarks | Moderators and FDA |
| 5:30pm | ADJOURN |
Documents
- Speaker Bios (PDF - 1.1 MB)
- Questions (PDF - 80 KB)
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