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. We are soliciting ideas for specific topics within these areas for discussion at the public workshop (see Registration). Ideas for the workshop will be accepted until August 19th (see Submit Comments). 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
• Registration
• Comments
• Contact
• References

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DATE and TIME

This virtual workshop will be held on October 24-25, 2022 beginning at 9:30 a.m until 4:30 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. More information will be made available as presenters and topics are confirmed.

REGISTRATION

• Submit Your Registration Here

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:

1. First Name
2. Last Name
3. Affiliation, Company, or Organization
4. Stakeholder category (Academia, Clinician, Consultant, Government, Industry, Press, Regulatory, and Other)
5. Email address
6. Telephone number

Registrants will receive confirmation when requests for participation have been accepted.

We are soliciting additional topics for discussion at the public workshop. If you are interested in proposing topics for consideration, please submit them to Docket (under Comments Section) within 4 weeks after this web announcement.

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, [email protected].

COMMENTS

We are soliciting additional topics for discussion at the public workshop. If you are interested in proposing topics for consideration, please submit them to Docket: FDA-2022-N-1542 by 4:00 pm (ET) August 19.

Please refer to the Instructions for Submitting Comments available in the Docket to ensure that your feedback is received. 

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
[email protected]

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