Abstract
Bioelectronic implants for vision restoration are medical devices regulated in the United States by the Food and Drug Administration (FDA). This paper provides an overview of regulatory pathways and related FDA programs for bioelectronic implants for vision restoration, and identifies some of the gaps in the regulatory science of these devices. The FDA recognizes that additional discussion regarding development in this space is needed to further develop bioelectronic implants and ensure that safe and effective technologies are made available to patients with profound vision loss. FDA regularly participates in the Eye and the Chip World Research Congress meetings and continues to engage with important external stakeholders, including through public workshops such as the recent co-sponsored Expediting Innovation of Bioelectronic Implants for Vision Restoration. By participating in forums for discussion of these devices with all stakeholders, especially patients, FDA seeks to encourage advancement of these devices.
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1. Regulation of bioelectronic implants for vision restoration
Bioelectronic implants are implantable medical devices intended for vision restoration that rely on electrical stimulation to induce visual perception. Bioelectronic implants for vision restoration may be positioned at different anatomical locations along the visual pathway, including intraocular as well as around the optic nerve and visual cortex. Patients with profound vision loss (PVL) due to degenerative eye conditions and/or trauma of the visual system may benefit from bioelectronic implants for vision restoration.
For the purposes of discussion, the Food and Drug Administration (FDA) defined PVL to be inclusive of the World Health Organization (WHO) International Classification of Diseases 11th revision (ICD-11) categories 4–6 [1]; however, there is a slight difference in that FDA includes visual acuity of '20/400 or worse' and is not considering visual field in this definition, as summarized in table 1 below.
Table 1. FDA definition of profound vision loss follows the WHO ICD-11 categorization (left), but includes equal to or better than 20/400.
| WHO ICD-11 [1] | Profound vision loss | ||
|---|---|---|---|
| Presenting distance visual acuity | |||
| WHO ICD-11 category | Worse than: | Equal to or better than: | |
| 0 No vision impairment | 6/125/10 (0.5) 20/40 | Includes categories 4–6, as well as 'equal to or better than 20/400' | |
| 1 Mild vision impairment | 6/125/10 (0.5) 20/40 | 6/183/10 (0.3) 20/70 | |
| 2 Moderate vision impairment | 6/183/10 (0.3) 20/70 | 6/601/10 (0.1) 20/200 | |
| 3 Severe vision impairment | 6/601/10 (0.1) 20/200 | 3/601/20 (0.05) 20/400 | |
| 4 Blindness | 3/601/20 (0.05) 20/400 | 1/601/50 (0.02) 5/300 (20/1200) or counts fingers (CF) at meter | |
| 5 Blindness | 1/601/50 (0.02) 5/300 (20/1200) | Light perception | |
| 6 Blindness | No light perception | ||
In the United States, most medical devices are regulated by the FDA within the Center for Devices and Radiological Health (CDRH). CDRH's mission is to protect and promote public health by assuring that patients and providers have timely and continued access to safe, effective and high-quality medical devices. CDRH provides consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the United States [2].
In order to expedite innovation of bioelectronic implants intended for vision restoration, it is imperative to understand the pathway to legally market a device in the United States. Per Section 201(h)(1) of the Federal Food, Drug and Cosmetic (FD&C) Act, a device is defined as:
'an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part, or accessory, which is—
FDA has a risk-based device classification system comprised of three classes that corresponds to the level of oversight needed to reasonably assure device safety and effectiveness, as summarized in table 2 [3].
Table 2. Device classification is based on risk, with the most stringent control for devices that are higher-risk (Class III).
| Class I | Class II | Class III | |
|---|---|---|---|
| Regulatory controls [4] | General controls | General controls Special controls | General controls Premarket approval (PMA) |
| Marketing submission | N/A; generally exempt from premarket notification, with some exceptions | Premarket notification (510(k)) | Premarket approval (PMA) |
| Risk level | Low to moderate risk devices | Moderate to high-risk devices | High risk devices |
a All devices classified as exempt are subject to the limitations of exemptions. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862–892.
General controls are the basic authorities that provide FDA a means of regulating devices to ensure their safety and effectiveness; these apply to all medical devices, unless exempted by regulations [5]. Examples of general controls are device adulteration and misbranding provisions, adverse event reporting and good manufacturing practice requirements.
For Class II devices, general controls alone are not sufficient to provide reasonable assurance of the safety and effectiveness of a device. Special controls are often specific to a device type and can include performance standards, postmarket surveillance, patient registries, special labeling requirements, premarket data requirements, guidelines, recommendations and other actions deemed necessary to provide assurance [4].
Premarket approval (PMA) [6] is necessary for Class III devices when general controls and special controls cannot provide reasonable assurance that a device is safe and effective for its intended use. Class III devices support or sustain human life or for a use of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury.
Device classification depends on the risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. When determining device classification, FDA considers both the risk the device poses to a patient or device user, as well as the intended use of the device as well as the indications for use [3].
Intended use (21 CFR § 801.4): The objective intent of the persons legally responsible for the labeling of (the medical device).
Indications for use (21 CFR § 814.20 (b)(3)(i)): A general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.
The intended use can be considered as the general purpose of the device or its function. The intended use encompasses the indications for use [7].
Ophthalmic devices span all three classifications for devices. In general, device types fall into a single classification (see examples in table 3). However, some may fall into different classifications based on the risk. For example, based on the level of risk and/or intended use(s), some contact lenses are Class III (e.g. extended wear), while others are Class II (e.g. daily wear disposables). Bioelectronic implants for vision restoration are typically considered high risk, Class III devices since they present a potentially unreasonable risk of illness or injury and general controls and special controls are not currently sufficient to mitigate the risks to health.
Table 3. Marketed ophthalmic device types (part 886 of the code of federal regulations (CFR) title 21).
| Class I (regulation) | Class II (regulation) | Class III (regulation) |
|---|---|---|
| Visual acuity chart [§ 886.1150] | Optical coherence tomography [§ 886.1850] | Intraocular lens [§ 886.3600] |
| Perimeter [§ 886.1605] | Ophthalmic camera [§886.1120] | Excimer laser systems |
| Amsler grid [§ 886.1330] | Optical biometer [§ 886.1850] | Intraocular gas [§ 886.4270] |
| Pupillometer [§ 886.1700] | Retinal diagnostic software [§ 886.1100] | Intraocular fluid [§ 886.4275] |
a PMA devices often involve new concepts, and many are not of a type marketed prior to the 1976 Medical Device Amendments. Therefore, such devices may not have a classification regulation identified in the CFR. In this case, the product classification database will only cite the device type name and product code [8].
1.1. Humanitarian device exemption (HDE) program
FDA is committed to advancing therapies for the treatment of rare diseases and conditions and has programs to encourage development of medical devices in these areas. The humanitarian use device (HUD) [9] and HDE [10] programs are examples of this commitment. A HUD is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8000 individuals in the United States per year (Section 3052 of the 21st Century Cures Act (Pub. L. No. 114-255)); a marketing application for a HUD (Section 520(m) of the FD&C Act)) is a HDE application.
HDE approval differs from PMA approval in important ways [11, 12]. FDA recognizes that rare diseases or conditions, such as retinitis pigmentosa, occur in a small number of patients. This makes it especially challenging to gather enough clinical evidence to meet the FDA PMA standard of reasonable assurance of safety and effectiveness. An important aspect of any HDE application for a HUD device, therefore, is an exemption from the effectiveness requirements that are necessary for PMA devices. There must be sufficient information to show a probable benefit, however.
To be eligible for an HDE application, a device (with intended use), must have received HUD designation and there cannot be a comparable device currently legally marketed in the United States. HUD designation occurs by submission of a request to the FDA Office of Orphan Products Development and involves determining whether the device is for a rare disease or condition that affects or is manifested in not more than 8000 individuals in the United States per year. There can be more than one approved HDE for the same intended use, but HDE approval expires with subsequent approval of a PMA for a particular intended use.
HDE approval authorizes the legal marketing of a HUD, but there are associated limitations, including that institutional review board (IRB) approval is required before the HDE-approved device is used (except in emergency situations a delay of 5 d prior to IRB notification is permitted), the labeling must clearly identify the device as a HUD and state that effectiveness has not been demonstrated, and that HDE devices may not be sold for profit (with limited exceptions).
1.2. Approved bioelectronic implant for vision restoration
To date, there has been one FDA approved retinal implant, the Second Sight Argus II Retinal Prosthesis System [13]. This device was approved as a HDE after it was designated as a HUD based on the incidence per year in the US. The Second Sight Argus II System is for patients with severe to profound retinitis pigmentosa, which has a prevalence of about 1 in 3000 to 1 in 4000 people in the world [14].
Intended use and indications for use for Argus II HUD (H110002 [13]):
Argus II intended use: to provide electrical stimulation of the retina to elicit visual perception in blind patients.
Argus II indications for use: The Argus II Retinal Prosthesis System is intended to provide electrical stimulation of the retina to elicit visual perception in blind patients. It is indicated for use in patients with severe to profound retinitis pigmentosa who meet the following criteria:
- Adults, age 25 years or older.
- Bare light or no light perception in both eyes. (If the patient has no residual light perception, then evidence of intact inner layer retina function must be confirmed.)
- Previous history of useful form vision.
- Patients who are willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation.
The Argus II implant is intended to be implanted in a single eye, typically the worse-seeing eye.
The approved indications for use for the Argus II device are based on evidence provided to support the safe use of the device in retinitis pigmentosa patients that meet specific criteria. The HDE Summary of Safety and Probable Benefit for the Argus II device [13] is a publicly available document, required by FDA regulations (21 CFR 814.104(b)(4)), that objectively summarizes the scientific evidence that served as the basis for HDE approval. This includes non-clinical and clinical review considerations, and information regarding benefit-risk assessment for the device.
2. Relevant FDA programs to support marketing of bioelectronic implants for vision restoration
CDRH is tasked with objectively determining whether implantable devices designed to restore vision are high-quality, safe and effective. There are multiple programs that could specifically benefit those that are developing bioelectronic implants for vision restoration (see figure 1), and who plan to submit a PMA or HDE.
Figure 1. FDA programs that could be used to support timely device innovation for bioelectronic implants; IDE: investigational device exemption; HDE: humanitarian device exemption; PMA: premarket approval.
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Table 4 provides some resources available on the FDA website, including FDA guidance documents.
Table 4. Links to FDA resources.
a FDA Guidance Documents are routinely updated, and new guidance documents are posted to the FDA website as they become available; the most recent version of a guidance document should always be referenced as it represents the most relevant FDA recommendations on a given subject. Note that guidance documents labeled as 'Draft' are posted for comment purposes only and are not final recommendations or for implementation.
What is an FDA guidance document? [15]
A document prepared for FDA staff, regulated industry, and the public that describe the FDA's interpretation of or policy on a regulatory issue. Guidance documents include, but are not limited to, documents that relate to:
- the design, production, labeling, promotion, manufacturing, and testing of regulated products
- the processing, content, and evaluation or approval of submissions
- inspection and enforcement policies.
Guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statue, regulations, or both.
2.1. Pre-submissions
The Q-Submission Program includes a number of different types of Q-Submissions that each provide a mechanism to request different types of interactions with FDA throughout product development. These are described in the Q-Submission Guidance Document [16]. Pre-Submissions, which are the most common type of Q-Submission, are formal requests for FDA feedback in the form of a written response and possibly a subsequent meeting, prior to an intended marketing submission or IDE. Pre-Submissions provide an opportunity to ask specific questions about non-clinical and clinical test plans. Because bioelectronic implants for vision restoration are innovative, iterative, and technologically complex, FDA recommends that Sponsors of device submissions (e.g. device manufacturers) come in early and often to discuss development of a device. Pre-Submissions provide an opportunity to obtain FDA feedback at various phases throughout the total product lifecycle. As described in the Q-Submission Guidance Document, some example of topics that can be discussed in a Pre-Submission include non-clinical testing (e.g. electrical safety, electromagnetic compatibility, sterility, biocompatibility, materials, durability, software, animal studies), or clinical trial design (clinical study protocol/design, safety and effectiveness endpoints, inclusion criteria, assessment methods, sample size, statistical analysis plan, etc).
The interplay between the Q-Submission Program and other programs is illustrated by the arrows in figure 1. For example, a Pre-Submission can be submitted prior to an investigational device exemption (IDE) early feasibility study (EFS) to receive feedback on bench testing and clinical study design; another Pre-Submission can be submitted prior to an IDE Pivotal Study, and yet another prior to submission of a PMA submission to discuss data presentation. IDE and EFS IDE studies are discussed in more detail below.
Following review of the Pre-Submission, FDA can provide formal written feedback within 70 d, or 5 d prior to a scheduled meeting, whichever is sooner. As part of this program, Sponsors may also request a meeting with the FDA review team to discuss the written feedback.
2.2. Investigational device exemption (IDE) studies
Clinical studies of significant risk devices (21 CFR § 812.3(m)), such as bioelectronic implants for vision restoration, will need to have an approved IDE before the study can be initiated. This is in addition to approval by an IRB. An IDE allows an investigational device to be used in a clinical study to collect safety and effectiveness data [18]. Devices with an approved IDE, while not approved for marketing, can lawfully be shipped for investigational purposes. Besides FDA and IRB approval of the IDE, there are several other provisions that must be followed when conducting IDE studies per 21 CFR part 812; these generally include informed consent from all patients, labeling stating the device is for investigational use only, study monitoring, study reporting, and more. Upon receipt of an IDE application, FDA has 30 calendar days to determine if the clinical trial may be initiated and begin enrollment of human subjects, or whether additional information is needed to address the FDA's concerns related to safety and patient protection measures. Bioelectronic implants for vision restoration are inherently complex in design, and there are not well-established testing methods, guidance and/or standards for evaluation. Therefore, FDA strongly encourages Sponsors developing these products to submit IDE study protocols for review in a Pre-Submission early in the device development and validation stages. This allows for non-clinical and study design concerns to be addressed through discussion outside of an IDE review, and may help ensure the data submitted are appropriate and adequate to support IDE approval.
In 2013, FDA published guidance on IDEs for Retinal Prostheses [19]. This document was meant to provide FDA reviewer staff and device manufacturers with the testing that is recommended to be included in an IDE submission to support initiation of a feasibility and/or pivotal human clinical trial of retinal prostheses to support a PMA or HDE. The guidance includes non-clinical (e.g. engineering, materials durability, hermeticity, electromagnetic compatibility, biocompatibility, safety, stimulation) recommendations as well as clinical study design and assessment recommendations for testing to characterize device safety and effectiveness. While the field of bioelectronic implants has evolved and expanded to other types of visual prosthetic devices, such as cortical implants, since this guidance was initially published, many elements of the document are applicable.
2.3. Early feasibility studies (EFSs) program
The FDA understands that there may be a greater level of uncertainty about how devices such as bioelectronic implants for vision restoration will perform if they are novel or have a new intended use. EFS allow Sponsors to gain initial clinical experience with a device in the early stages of development to provide proof of principle and initial clinical safety data [17]. Data obtained from an EFS are not meant to support a marketing application but can provide valuable information to help finalize device design.
EFS IDEs can be used to advance device development when information cannot be practically obtained with non-clinical assessments or if non-clinical tests are unavailable. Whereas a pivotal trial is typically designed to collect definitive evidence of safety and effectiveness of a device using a statistically justified number of subjects, EFS enrollment is generally limited to 10 or fewer initial subjects with an emphasis on patient safety. FDA considers benefit-risk and adequate human subject protection measures when reviewing all IDE studies, including EFS. Sponsors are encouraged to include a device evaluation strategy (DES) as part of their EFS IDE submission to systematically identify the information needed to address significant safety concerns and support basic device function. A benefit of the DES approach is that there may be circumstances under which a Sponsor can justify deferring some non-clinical testing until after the EFS phase.
The EFS program could support the development of bioelectronic implants for vision restoration by enabling initial device insights regarding device safety, human factors/usability engineering considerations, operator technique challenges, device failure modes, therapeutic parameters, or whether the device performs its intended purpose for a specific patient population. This could help Sponsors optimize device development, refine the intended use, define the target patient population, or develop future investigational protocols. The EFS Program has been used by multiple developers of these devices including the Second Sight Orion cortical visual prosthesis system, the Pixium Vision PRIMA sub-retinal implant [23, 24]. This has enabled initial investigations of implanted devices in patients that would otherwise not be possible in the US at such early stages of development, and may include patients blinded from glaucoma, diabetic retinopathy, or trauma (Orion), and patients with Atrophic Dry Age-related Macular Degeneration (PRIMA). As with other IDEs, FDA recommends a Pre-Submission with complete study protocol prior to submitting an EFS IDE.
2.4. Breakthrough devices program
FDA has voluntary programs to expedite innovation in an effort to provide patients in the United States with access to high-quality, safe and effective medical devices, first in the world. The FDA is particularly interested in areas where there are limited treatment options or where promising technologies may provide for more effective treatment than existing alternatives. The Breakthrough Devices Program was initiated by the passage of the 21st Century Cures Act and replaced the previous Expedited Access Pathway (EAP) [20]. The Program is intended to expedite development, assessment, and review, while preserving statutory standards for marketing authorization. The Breakthrough Devices Program may particularly benefit those developing implants for vision restoration. To be eligible for the Breakthrough Devices Program, specific designation criteria must be met:
First criterion: The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
Second criterion: The device also meets at least one of the following:
- (a)Represents breakthrough technology
- (b)No approved or cleared alternatives exist
- (c)Offers significant advantages over existing approved or cleared alternatives
- (d)Device availability is in the best interest of patients.
Requests for Breakthrough Device designation are made by submitting a 'Designation Request for Breakthrough Device' Q-Submission. If a device is granted Breakthrough Device designation, the program allows many benefits, including interactive and timely communication, pre/postmarket balance of data collection, efficient and flexible clinical study design, review team support, and engagement of senior management, priority review, and opportunities for reduced manufacturing information in a PMA; regulatory requirements remain in place but participation in the program does not add any new requirements. After being granted Breakthrough Device designation, additional requests for FDA feedback and interactions can be submitted as an 'Interaction for Designated Breakthrough Device' through the Q-Submission Program. Additional information on the Breakthrough Devices Program and the submission process can be found in the Breakthrough Device Program Guidance Document [20].
As of 31 December 2022 [20], a total of 760 Breakthrough Device designations (including devices designated under the precursor EAP) have been granted by CDRH and the Center for Biologics Evaluation and Research; 17 of these designations were within the Ophthalmic Devices Clinical Panel. As an example, the Orion Cortical Visual Prosthesis System received Breakthrough Device Designation in 2018 [25]. Sponsors developing other bioelectronic implants for vision restoration may also benefit from the enhanced interactions offered by the Program because these devices are complex, innovative, and have different benefit-risk considerations compared to other device types.
2.5. Incorporating the patient voice
Clinical outcome assessments (COAs) describe or reflect how a person feels, functions, or survives and can be reported by a health care provider (clinician-reported outcome), a patient (patient-reported outcome), a non-clinical observer (such as a spouse; observer-reported outcome), or through performance of an activity or task (performance outcome) [26, 27]. Information obtained using COAs has the potential to provide valuable information to assist with benefit-risk determination during regulatory review. COAs could be used to help determine who is eligible for a clinical study or to measure device safety. These could also be used as a way to systematically capture clinically meaningful outcomes that are important to patients by measuring how well a device performs when used to treat a specific condition, such as PVL.
However, existing COAs are insufficient for evaluating patients with PVL. These tools may need modification or new tools may need to be developed to ensure they are fit-for-purpose for their roles (e.g. safety or effectiveness; primary, secondary, or ancillary) in a clinical study protocol and statistical analysis plan [28].
In addition, patients and caregivers may weigh the benefits and risks of an invasive technology differently than regulators or healthcare providers. Patient preference information is defined as qualitative or quantitative assessments of the relative desirability or acceptability to patients of specified alternatives or choices among outcomes or other attributes that differ among alternative health interventions [29, 30]. FDA is interested in more fully understanding the impact of PVL and patient preference for treatment options, and will consider this as part of an evaluation of bioelectronic implants for vision restoration.
Additional information is often helpful for FDA to identify treatment outcome priorities for patients living with PVL, and patient preference information can help to clarify what is most important to them—for example, independence, activities of daily living, mobility.
FDA encourages Sponsors developing bioelectronic implants for vision restoration to consider COAs and patient preference information when designing and validating their devices. Questions about data collection methods can be included as part of a Pre-Submission.
2.6. Medical device development tool (MDDT) program
The MDDT Program is a voluntary tool qualification pathway that was developed to advance innovation, increase predictability for Sponsors, improve efficiency and transparency, and encourage collaboration in developing tools and supporting evidence [22]. When evaluating a device for safety and effectiveness, FDA must also ensure that the assessment methods are validated. For many devices or technologies, FDA may recognize industry accepted methodologies, such as those included in FDA Recognized Voluntary Consensus Standards documents, to ensure safety and/or effectiveness. When new technologies are developed, however, such methods may not exist or may lack consensus and Sponsors are then burdened by developing their own approaches and demonstrating to the FDA the approaches are scientifically valid. The FDA has to review the adequacy of the data in the device marketing application while simultaneously evaluating whether the data collection methods are appropriate. MDDTs are meant to reduce the uncertainty associated with regulatory review when Sponsors need to create their own assessment methods as they develop a device, and to allow stakeholders to utilize common approaches, where possible.
A MDDT is a method, material, or measurement used to assess the safety, effectiveness, or performance of a medical device. A MDDT should be scientifically validated and qualified for a specific context of use (COU). The COU describes how the MDDT should be used, its purpose in device evaluation and/or a regulatory submission, and specific output/measure from the tool.
Qualification is an FDA conclusion that, within the COU, a MDDT can be relied upon to have a specific interpretation and application to demonstrate safety, effectiveness, or performance for a medical device during regulatory review. CDRH reviewers should accept the validation of the MDDT methodology when used in a regulatory submission according to the qualified COU, without the need to reconfirm the suitability and utility of the MDDT. Some examples of MDDTs include COAs, biomarker tests, and non-clinical assessment models. The MDDT program may help bridge the gap with respect to regulatory needs and standardization of methods for evaluating bioelectronic implants for vision restoration.
3. Advancing regulatory science to support development of bioelectronic implants for vision restoration
Currently, there is a lack of consensus on terminology, endpoints, and assessment methods for bioelectronic implants for vision restoration [31]. The FDA IDE Guidance for Retinal Prostheses [19] discusses aspects of device basic safety evaluation, including recommendations for establishing adequate safety using non-clinical testing prior to initiating studies in humans. Primary safety and effectiveness endpoints are needed in clinical studies for bioelectronic implants for vision restoration to support a marketing application. However, there are not well-established, universally-accepted, clinical endpoints for the evaluation of safety or effectiveness, since this is complicated by differences in implant type, anatomical location, intended use, patient population, and etiology.
There have been varying approaches to objectively measuring effectiveness of bioelectronic implants for vision restoration because these devices have unique considerations [32–35]. Established methods, such as visual acuity testing with the Early Treatment Diabetic Retinopathy Study chart, are meant for measuring patients with less severe vision loss. These approaches were designed for a different purpose and not to measure meaningful improvement in visual function attributable to implantable technology in patients with PVL.
Quantitative measures of visual acuity also do not account for important aspects of the impact of vision loss on orientation, mobility, independence, activities of daily living, quality of life, social interactions, mental health or overall wellbeing [36–38]. These aspects could potentially be captured using a combination of measures of visual function, such as motion or color vision, or with other methods for understanding functional vision, including mobility assessments or PROs [39–53], after they are validated for use in patients with PVL.
Validated, consistent measures are needed to quantify the effectiveness of implantable vision restoration devices. Further discussion and development of assessment methods for bioelectronic implants for vision restoration is essential to support the regulatory advancement of these technologies so that they may become more accessible to patients.
Over the last two decades, CDRH's Ophthalmic Division has led or contributed to numerous public forums in an effort to obtain consensus on clinical trial design of novel technologies [54–64]. These proved to be impactful in expediting innovation. To support the development of bioelectronic implants for vision restoration, the Ophthalmic Division has also partnered with the University of Pittsburgh. Together with a steering committee representing patient organizations, device developers, researchers, and government agencies, we held a virtual public workshop titled 'Expediting Innovation of Bioelectronic Implants for Vision Restoration' on 24–25 October 2022. This workshop provided a forum for all stakeholders, including patients, families, healthcare providers, researchers, and device manufacturers, to discuss the background, current state, and future development of these devices, as well as to confront the much-needed consensus on appropriate safety and effectiveness assessments considering the patient perspective. FDA intends to support continued discussions regarding the development of these devices.
4. Conclusion
FDA is committed to the advancement of bioelectronic implants for vision restoration so that patients can have access to safe, effective, high-quality devices. Multiple FDA programs exist to support innovation in this area and FDA encourages Sponsors to interact early and often throughout development of these devices. In order to expedite the development of these technologies, FDA also co-sponsored a workshop, 'Expediting Innovation Bioelectronic Implants for Vision Restoration'. Moving forward, FDA hopes to continue to engage stakeholders to fill in the gaps with respect to assessment methodology and enable regulatory review consistency that will ultimately support the development, approval, and availability of bioelectronic implants for vision restoration.
Data availability statement
No new data were created or analyzed in this study.
Conflict of interest
None (all authors).
Data access
Data access is not applicable to this work. This is a summary of a presentation given by FDA during the Eye and the Chip Congress in October 2021.
Funding
Funding sources are not applicable to this work. This is a summary of a presentation given by FDA during the Eye and the Chip Congress in October 2021.