# 2026-22590: FDA regulates software predicting the future of mild cognitive impairment 2026-22590, Medical Devices; Neurological Devices; Classification of the Prognostic Assessment Software of Mild Cognitive Impairment, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-11-05, effective 2026-11-05; PRIA reads it as touching household money (as of 2026-11-06). - Canonical: https://policyrisk.com/federal-register/2026-22590 - As of: 2026-11-06 - Plain-text twin of the page above; the HTML and this file carry the same facts. ## Facts - Document number: 2026-22590 - Title: Medical Devices; Neurological Devices; Classification of the Prognostic Assessment Software of Mild Cognitive Impairment - Type: Rule - Agencies: Health and Human Services Department; Food and Drug Administration - Citation: 91 FR 69690 - Published: 2026-11-05 - Effective: 2026-11-05 - Comments close: not stated - Significant: no - Touches household money: yes - Regulation identifier numbers: none - Last updated: 2026-11-06 ## In one line FDA regulates software predicting the future of mild cognitive impairment ## Summary The FDA is officially putting mild cognitive impairment prognostic software into Class II, meaning it now has special safety rules but fewer hurdles than the strictest category. This change helps patients get access to these helpful tools faster and ensures the devices are safe and effective. The new rules took effect November 5, 2026, but have been in place since January 11, 2024, giving companies clear guidance on what’s expected. ## Abstract The Food and Drug Administration (FDA) is classifying the prognostic assessment software of mild cognitive impairment into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the prognostic assessment software of mild cognitive impairment. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. ## Effects PRIA read - Device moved to Class II (faster access): benefit, medium. The FDA officially classified prognostic assessment software of mild cognitive impairment as Class II (special controls), effective November 5, 2026, with the classification applicable January 11, 2024. FDA says this Class II classification provides reasonable assurance of safety and effectiveness… - Premarket 510(k) requirement remains: cost, medium. The device type is subject to premarket notification under section 510(k) of the FD&C Act unless FDA later exempts it; FDA has not exempted this device at this time. Companies seeking to market these devices must submit a 510(k) to reasonably assure safety and effectiveness. - Special controls require testing, labeling, and software validation: mixed, medium. To be in Class II, these devices must meet special controls including: clinical performance testing (including accuracy, precision, reproducibility; independent test data representative of intended patients), reporting objective performance measures (e.g., sensitivity, specificity, positive/negativ… - Prescription-only, adjunctive use requirement: cost, low. FDA identifies prognostic assessment software of mild cognitive impairment as a prescription-only device that is intended for adjunctive use and is not a stand-alone diagnostic or prognostic tool. The device output must be interpreted in the context of all clinical information. - De Novo classification enables predicate for future devices: benefit, medium. FDA used the De Novo process for this device type, meaning the device can serve as a predicate for future devices; other sponsors can rely on 510(k) pathways to market substantially equivalent devices rather than submitting new De Novo requests or premarket approval applications. ## Related documents - [2026-20848](https://policyrisk.com/federal-register/2026-20848): Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods, 2026-10-13 - [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11 - [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13 - [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29 - [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25 - [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27 ## Sources - [2026-22590 on federalregister.gov](https://www.federalregister.gov/documents/2026/11/05/2026-22590/medical-devices-neurological-devices-classification-of-the-prognostic-assessment-software-of-mild) - [2026-22590 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-11-05/pdf/2026-22590.pdf) ## Related - [Previous: 2026-22589, Medical Devices; Orthopedic Devices; Classification of the Wearable Vibration D…](https://policyrisk.com/federal-register/2026-22589) - [Next: 2026-22593, Medical Devices; Hematology and Pathology Devices; Classification of the Digita…](https://policyrisk.com/federal-register/2026-22593) - [All Federal Register documents](https://policyrisk.com/federal-register) Source: PRIA, https://policyrisk.com/federal-register/2026-22590 (as of 2026-11-06).