21 CFR 882.1454 — Prognostic Assessment Software Of Mild Cognitive Impairment
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1454
Identification
Prognostic assessment software of mild cognitive impairment is a prescription-only device that combines information from multiple clinical data sources to produce an output indicative of the likelihood that a patient diagnosed with mild cognitive impairment will progress to more severe forms of cognitive impairment, or will develop dementia, such as Alzheimer's disease dementia, within a specified period of time. This device is intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic tool.
Classification Rationale
Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks when considering the listed special controls and general controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QWT | Prognostic Assessment Software Of Mild Cognitive Impairment | 2 | 1 | SaMD |
Special Controls
QWT — Prognostic Assessment Software Of Mild Cognitive Impairment
In combination with the general controls of the FD&C Act, the prognostic assessment software of mild cognitive impairment is subject to the following special controls:
De Novo Order DEN220066
