2016 Bulletin

24 | Bulletin vol. 30 no. 2 FDA Seeks Input on Neurodiagnostic Cognitive Assessment and External Neurostimulation Devices Robin C. Hilsabeck, Ph.D. INC Research Tresa Roebuck-Spencer, Ph.D. Private Practice The Federal Drug Administration (FDA) hosted a public workshop on November 19-20, 2015 to seek input on cognitive assessment medical devices (e.g., computerized cognitive batteries) and non-invasive brain stimulation medical devices (e.g., transcranial magnetic stimulation). The overarching goal of the workshop was to further develop risk-based strategies within a regulatory framework that will facilitate advances in the technology while maintaining appropriate consumer protections. The first day of the workshop focused on neurodiagnostic devices to assess cognitive functioning and built upon what was learned from their prior public workshop on seizure detection, cognitive function, and TBI/concussion devices in June 2011, which was co-sponsored by NAN, the American Academy of Neurology, and the American Epilepsy Society and led to a joint position paper by NAN and the American Academy of Clinical Neuropsychology1. The second day focused on external neurostimulation devices intended to improve normal cognitive functioning in healthy individuals. Format of FDA Workshop The format for both days was similar and included an introduction to the day's topic, an overview of the FDA's perspective on the topic, state of the science presentations by leaders in the field, panel discussions of risks and benefits by various stakeholders, and breakout sessions to seek public input into benefit and risk considerations, current scientific and clinical evidence, ethical considerations, and clinical trial design considerations. In addition, representatives from several government agencies presented overviews of their agencies and how their agency was relevant to the discussion of regulating these devices for their intended uses. For example, an attorney from the Federal Trade Commission (FTC), Michelle Rusk, explained that their broad mandate is to stop deceptive and unfair practices in commerce (e.g., companies such as Lumosity making false and unsubstantiated marketing claims). She encouraged the public to help the FTC regulate these devices by contacting them when there is concern about the validity of claims made in advertising (concerns about labeling claims should be directed to the FDA). Although all discussions were relevant to clinical neuropsychologists, highlighted in this summary are specific aspects of the workshops that might be of most interest to NAN members. Highlights from Day 1: Neurodiagnostic Devices With regard to the neurodiagnostic devices topic, it is important for neuropsychologists to know that the FDA considers computerized cognitive measures, including tests that assess a single cognitive ability (e.g., reaction time) and those that measure multiple cognitive functions (e.g., a test battery), to be under the purview of neurodiagnostic medical devices that may require FDA regulation. It was noted that many of these devices do not yet have FDA regulations so this is an emerging area. An example of one of the topics the FDA was seeking input about was how differences in intended use of a neurodiagnostic device would affect the risk-benefit profile (e.g., what kind of protections need to be in place if a device is intended to be used to identify a specific cognitive deficit versus to screen for cognitive impairment?). Recent FDA approvals of neurodiagnostic devices used for assessment of cognitive functioning were discussed, including Cognivue, which has been approved "for use as an adjunctive tool for evaluating perceptual and memory function in individuals aged 55-95 years old" as written in the FDA approval letter dated June 5, 2015. The FDA approved this device as a class II computerized cognitive assessment aid that is not intended to be used as a stand-alone or adjunctive diagnostic device. Deborah Wolf from the FDA cautioned in her presentation that when a device is approved as an aid in assessing, the company should not make any statements about the device detecting or diagnosing, which would be considered a false or misleading claim, going beyond the scope of intended use, and subject to investigation and potential penalties. The only other computerized test mentioned specifically was DANA, which has been cleared by the FDA as a "tool that provides an objective measurement of reaction time." Of note, other computerized cognitive batteries have also been cleared by the FDA, and there may be other computerized cognitive batteries undergoing this process currently. Highlights from Day 2: External Neurostimulation Devices With regard to the external neurostimulation devices topic, the discussion was limited to those devices that "apply external electromagnetic neurostimulation to the head, with the intent of improving, enhancing, or otherwise favorably altering normal cognitive function in healthy individuals" (p. 3 of the Discussion Paper on this topic provided by the FDA as workshop materials). The intent of these devices could be to affect the structure (anatomy) or function (physiology) of the brain but not to prevent or treat medical conditions. Of particular interest to the FDA in order to provide regulatory oversight on these devices are considerations of whether the use of the device presents a potential unreasonable risk of illness or injury and how devices may relate to other medical devices that deliver energy externally to the head. It was acknowledged that research on external neurostimulation devices intended to improve normal cognitive functioning in healthy individuals is limited but is a rapidly evolving area of interest to the FDA. In fact, the FDA has played a

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