Workshop
Event Title
Co-sponsored Public Workshop - Expediting Innovation of Bioelectronic Implants for Vision Restoration
October 24 - 25, 2022
- Date:
- October 24 - 25, 2022
- Time:
- 8:30 AM - 3:30 PM ET
SUMMARY
The Food and Drug Administration (FDA) is announcing a co-sponsored public workshop with the University of Pittsburgh entitled, "Expediting Innovation of Bioelectronic Implants for Vision Restoration." The purpose of this workshop is to provide a forum for all stakeholders, including patients, clinicians, manufacturers, regulators, and professional societies to share their perspectives on the safety and effectiveness of bioelectronic implants for vision restoration.
BACKGROUND
In 2017, more than 1 million people in the US met the definition of blindness (with 20/200 best-corrected visual acuity or less in the better-seeing eye)1,2 By 2050, this number is projected to increase to 4 million based on shifting demographics and an aging population.3 One approach to treating those with profound vision loss (e.g., patients suffering from late stage age-related macular degeneration, retinitis pigmentosa, trauma) is to use bioelectronic implants (e.g., retinal and cortical implants). These devices aim to achieve artificial perception, restore vision and aid in the achievement of tasks of daily living. However, there are unique considerations and technological challenges associated with the development and assessment of bioelectronic implants for vision restoration.
This public workshop aims to foster a conversation about these challenges and include discussions regarding the relevant regulatory pathways for these types of implants, nonclinical data requirements, possible novel safety and effectiveness clinical endpoints, aspects of technology translation, possible methods to conduct real-life daily activities assessments for low vision patients, and possible methods to collect patient reported outcome measures related to bioelectronic implants for vision restoration. The workshop will also include discussions related to patient perspectives and experiences with bioelectronic implants, and some of the elements that are important to patients when considering the benefits and risks of using these devices.
The FDA and University of Pittsburgh plan to release a summary of the proceedings following the workshop to share key takeaways from panel discussions, breakout sessions, and comments received.
- Date and Time
- Webcast
- Preliminary Agenda
- Steering Committee Biosketches
- Registration
- Comments
- Contact
- References
DATE and TIME
This virtual workshop will be held on October 24-25, 2022 beginning at 8:30 a.m until 3:30 p.m ET
WEBCAST
The co-sponsored public workshop will be webcasted, and the link will be provided in your confirmation email if you registered to view the webcast. The link for the archived webcast will be posted to the webpage for viewing after the workshop.
PRELIMINARY AGENDA
The following public workshop agenda is preliminary and subject to change.
Time (Eastern) | Topic | Name of Session Chair / Speakers |
---|---|---|
8:30 am - 8:45 am | Day 1: Welcome and Introduction | Malvina Eydelman, MD Food and Drug Administration |
8:45 am - 10:15 am | SESSION 1: Bioelectronic Implants and Public Health Impact | |
8:45 am - 9:05 am | Why do we need Bioelectronic Implants? | José-Alain Sahel, MD University of Pittsburgh |
9:05 am - 9:25 am | Psychological Considerations | Thiran Jayasundera, MD University of Michigan |
9:25 am - 9:45 am | Socioeconomic Considerations | Nabin Paudel, PhD Retina International |
9:45 am - 10:05 | Ethical Considerations | Joseph Fins, MD Weill Cornell Medicine |
10:05 am - 10:15 am | Patient Experiences | |
10:15 am - 10:25 am | Break | |
10:25 am - 12:15 pm | SESSION 2: Technology and Regulation | |
10:25 am - 10:45 am | Subretinal Implants | Daniel Palanker, PhD Stanford University |
10:45 am - 11:05 am | Epiretinal Implants | Mark Humayun, MD, PhD University of Southern California Institute for Biomedical Therapeutics |
11:05 am - 11:25 am | Cortical Implants | Nader Pouratian, MD, PhD UT Southwestern Medical Center |
11:25 am - 11:35 am | Patient Experiences | |
11:35 am - 12:15 pm | Regulatory Background & Requirements |
Michelle Sandrian, PhD Lan Yue, PhD |
12:15 pm - 1:15 pm | Break | |
1:15 pm - 3:15 pm | SESSION 3: Patient Perspectives | |
1:15 pm - 2:15 pm | Patient Panel Introductions | |
2:15 pm - 3:15 pm | Moderated Patient Panel Discussion | Moderator: Eva Rorer, MD Food and Drug Administration |
3:15 pm - 3:25 pm | Day 1: Wrap-Up | Tieuvi Nguyen, PhD Food and Drug Administration |
Time (Eastern) | Topic | Name of Session Chair / Speakers |
---|---|---|
8:30 am - 8:35 am | Day 2: Welcome & Recap | Tieuvi Nguyen, PhD Food and Drug Administration |
8:35 am - 9:45 am | SESSION 4: Evaluation of Bioelectronic Implants: Safety | |
8:35 am - 9:05 am | Bioelectronic Implants: Overview of Clinical Safety Endpoints and Evidence | James Weiland, PhD University of Michigan |
9:05 am - 9:45 am | Moderated Q&A: Safety of Bioelectronic Implants |
Moderator: Michael Repka, MD, MBA Panelists:
|
9:45 am - 10:00 am | Break | |
10:00 am - 11:30 am | SESSION 5: Clinical Outcome Assessments and Patient Preference | |
10:00 am - 10:20 am | FDA Regulatory framework for Clinical Outcomes Assessments and Patient Preference |
Fraser Bocell, PhD David Gebben, PhD |
10:20 am - 10:40 am | Clinical Outcomes Assessment for Bioelectronic Implants: NEI Perspective | Emily Chew, MD National Eye Institute |
10:40 am - 11:10 am | Clinical Outcomes Assessment and Performance-Based Testing for Bioelectronic Implants: University of Pittsburgh |
Emily Grattan, PhD, OTR/L Rakie Cham, PhD Jose Sahel, MD |
11:10 am - 11:30 am | Moderated Q&A: Clinical Outcomes Assessment for Bioelectronic Implants |
Moderator: Michelle Tarver, MD, PhD Panelists:
|
11:30 am - 12:20 pm | Break | |
12:20 pm - 1:30 | SESSION 6: Effectiveness | |
12:20 pm - 12:50 pm | Bioelectronic Implants: Overview of Clinical Effectiveness Endpoints and Evidence | Gislin Dagnelie, PhD Johns Hopkins University |
12:50 pm - 1:30 pm | Moderated Q&A: Effectiveness of Bioelectronic Implants |
Moderator: Elvin Ng Panelists:
|
1:30 pm - 2:30 pm | SESSION 7: Post-market Considerations | |
1:30 pm - 1:50 pm | FDA: Post-Approval Studies, Postmarket Surveillance and Real World Evidence | Nilsa Loyo-Berrios, PhD Food and Drug Administration |
1:50 pm - 2:00 pm | Patient Experiences | |
2:00 pm - 2:30 pm | Moderated Q&A: Post-Market Considerations |
Michael Repka, MD, MBA Panelists:
|
2:30 pm - 3:30 pm | SESSION 8: Government Agency Opportunities for Device Innovation | |
2:30 pm - 3:00 pm | Government Agency Programs for Bioelectronic Implants |
Sohi Rastegar, PhD Paek Lee, PhD Lina Kubli, PhD Tian Wang, PhD Joeanna Arthur, PhD Elvin Ng |
3:00 pm - 3:30 pm | Moderated Q&A: Government Agency Opportunities for Device Innovation |
Co-moderators: Jose Sahel, MD Panelists:
|
3:30 pm - 3:35 pm | Day 2: Workshop Concluding Remarks and Next Steps |
Jose Sahel, MD Malvina Eydelman, MD |
STEERING COMMITTEE BIOSKETCHES
Expediting Innovation of Bioelectronic Implants for Vision Restoration Public Workshop Biosketches
REGISTRATION
If you wish to attend this workshop, you must register by 4:00 p.m. ET on October 20, 2022. There is no fee to register for the public workshop and registration will be on a first-come, first-served basis. When registering, you must provide the following information:
- First Name
- Last Name
- Affiliation, Company, or Organization
- Stakeholder category (Academia, Clinician, Consultant, Government, Industry, Press, Regulatory, and Other)
- Email address
- Telephone number
Registrants will receive confirmation when requests for participation have been accepted.
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: FDA-2022-N-1542 by November 22, 2022.
Please refer to the Instructions for submitting comments (Regulations.gov) to the docket to ensure that your feedback is received.
The Docket is no longer accepting comments on topics for discussion for this workshop.
The resulting discussions from the workshop and comments received in the docket will be taken into consideration.
CONTACT
For questions regarding workshop content, please contact:
Michelle Gabriele Sandrian
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
301-796-6620
CDRH-VisionWorkshop@fda.hhs.gov
REFERENCES
1 Centers for Disease Control and Prevention Prevalence Estimates, available at: https://www.cdc.gov/visionhealth/vehss/estimates/index.html
2 Flaxman AD, Wittenborn JS, Robalik T, Gulia R, Gerzoff RB, Lundeen EA, Saaddine J, and Rein DB, Prevalence of Visual Acuity Loss or Blindness in the US. JAMA Ophthalmol. 2021; 139(7):717-723.
3 Blindness Data and Statistics from the National Eye Institute, available at: https://www.nei.nih.gov/learn-about-eye-health/outreach-campaigns-and-resources/eye-health-data-and-statistics/blindness-data-and-statistics
Event Materials
Title | File Type/Size |
---|---|
Expediting Innovation of Bioelectronic Implants for Vision Restoration Biosketches | pdf (992.03 KB) |