- October 24 - 25, 2022
- 8:30 AM - 3:30 PM ET
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.
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
- Steering Committee Biosketches
This virtual workshop will be held on October 24-25, 2022 beginning at 8:30 a.m until 3:30 p.m ET
|Time (Eastern)||Topic||Name of Session Chair / Speakers|
|8:30 am - 8:45 am||Day 1: Welcome and Introduction||
|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?||
|9:05 am - 9:25 am||Psychological Considerations||
|9:25 am - 9:45 am||Socioeconomic Considerations||
|9:45 am - 10:05 am||Ethical Considerations||
|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||
|10:45 am - 11:05 am||Epiretinal Implants||
|11:05 am - 11:25 am||Cortical Implants||
|11:25 am - 11:35 am||Patient Experiences|
|11:35 am - 12:15 pm||Regulatory Background & Requirements||
|12:15 pm - 1:15 pm||Break|
|1:15 pm - 2:40 pm||SESSION 3: Patient Perspectives|
|1:15 pm - 1:40 pm||Patient Panel Introductions|
|1:40 pm - 2:40 pm||Moderated Patient Panel Discussion||
|2:40 pm - 2:50 pm||Day 1: Wrap-Up||
|Time (Eastern)||Topic||Name of Session Chair / Speakers|
|8:30 am - 8:35 am||Day 2: Welcome & Recap||
|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||
|9:05 am - 9:45 am||Moderated Q&A: Safety of Bioelectronic Implants||
|9:45 am - 9:55 am||Break|
|9:55 am - 11:35 am||SESSION 5: Clinical Outcome Assessments and Patient Preference|
|9:55 am - 10:20 am||FDA Regulatory framework for Clinical Outcomes Assessments and Patient Preference||
|10:20 am - 10:40 am||Clinical Outcomes Assessment for Bioelectronic Implants: NEI Perspective||
|10:40 am - 11:10 am||Clinical Outcomes Assessment and Performance-Based Testing for Bioelectronic Implants: University of Pittsburgh||
|11:10 am - 11:15 am||Patient Experiences|
|11:15 am - 11:35 am||Moderated Q&A: Clinical Outcomes Assessment for Bioelectronic Implants||
|11:35 am - 12:20 pm||Break|
|12:20 pm - 1:30 pm||SESSION 6: Effectiveness|
|12:20 pm - 12:50 pm||Bioelectronic Implants: Overview of Clinical Effectiveness Endpoints and Evidence||
|12:50 pm - 1:30 pm||Moderated Q&A: Effectiveness of Bioelectronic Implants||
|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||
|1:50 pm - 2:00 pm||Patient Experiences|
|2:00 pm - 2:30 pm||Moderated Q&A: Post-Market Considerations||
|2:30 pm - 3:40 pm||SESSION 8: Government Agency Opportunities for Device Innovation|
|2:30 pm - 3:10 pm||Government Agency Programs for Bioelectronic Implants||
|3:10 pm - 3:40 pm||Moderated Q&A: Government Agency Opportunities for Device Innovation||
|3:40 pm - 3:45 pm||Day 2: Workshop Concluding Remarks and Next Steps||
Online registration is now closed. The links to view the webcast are posted under the Webcast portion of this web announcement.
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.
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
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
|Expediting Innovation of Bioelectronic Implants for Vision Restoration Biosketches||pdf (992.03 KB)|
|Transcript - October 24, 2022||pdf (932.19 KB)|
|Transcript - October 25, 2022||pdf (1.37 MB)|