FDA Workshop to Focus on Cognitive Assessment Devices

Early this summer, the FDA granted de novo approval to a computer-based tool to assess cognitive decline that may lead to dementia. With more companies looking to develop similar assessment tools, the FDA says it hopes to encourage innovation in this area.

To that end, the agency has scheduled a workshop for Nov. 19 and 20 to gather input on potential guidance for premarket submissions.

Day one will focus on cognitive assessment devices, which are used to determine if a patient experiencing memory loss and other symptoms needs further evaluation. Discussions for the second day will center on noninvasive brain simulation devices that deliver electrical or electromagnetic stimulation to the head to improve, affect or modify the cognitive function of an individual who is not seeking treatment for a specific condition.

In an Aug. 14 Federal Register notice, the agency says these devices present questions related to safety and effectiveness, as well as study design and data analysis challenges.

Topics slated for discussion include:

• Considerations for clinical study trial designs, patient populations and patient selection methods;
• Considerations for clinical study endpoints, e.g., clinically relevant outcome measures and related statistical analyses;
• Identification of risks and risk mitigation strategies; and
• Evaluation of prior studies, current clinical research and available scientific and clinical evidence.

Interested parties may submit comments on workshop topics until Dec. 5.

To read the Federal Register notice, visit www.fdanews.com/081715-brain-meeting.pdf.
– Elizabeth Hollis