Digital Cognitive Assessments for Alzheimer's: FDA Classification, Labeling and Trial Use

How FDA classifies digital cognitive tests

FDA regulates many app- and tablet-based cognitive batteries under 21 CFR 882.1470, "Computerized cognitive assessment aid": "A prescription device that uses an individual's score(s) on a battery of cognitive tasks to provide an interpretation of the current level of cognitive function." The regulation adds that the device "does not identify the presence or absence of clinical diagnoses" and "is not intended as a stand-alone or adjunctive diagnostic device." It is Class II with special controls.

510(k) exemption. These devices are exempt from 510(k) "except when the computerized cognitive assessment aid is intended for diagnostic assessment of specific diseases or conditions and relies on inputs from visual cues, auditory cues, and/or functional use of the hand" (subject to the limits in § 882.9).

Required labeling includes, where available, adverse events; "sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)"; repeatability; how cut-offs were set; construct validity; and warnings that the device does not diagnose and "is not a stand-alone diagnostic."

Source: 21 CFR 882.1470 (eCFR). This page is a summary, not medical or regulatory advice.

Product codes and FDA records

openFDA lists two product codes under 882.1470: PKQ ("Computerized Cognitive Assessment Aid") and PTY ("Computerized Cognitive Assessment Aid, Exempt"), both Class II. Exempt (PTY) products have no premarket record, so there is no public FDA list of them. The table shows the PKQ premarket records in openFDA. It is a partial view of the market, and we have not summarized intended use: read each summary on FDA's database. Clearance or a De Novo grant is not FDA approval.

Sources: openFDA classification; openFDA 510(k) records, PKQ; checked on the FDA 510(k) database and FDA De Novo database. openFDA describes its data as unvalidated.

Using cognitive tests in Alzheimer's drug trials

FDA's "Early Alzheimer's Disease: Developing Drugs for Treatment" remains a draft guidance; a revised draft was announced March 12, 2024. For tests run remotely on a phone, tablet or wearable, FDA's final guidance on digital health technologies for remote data acquisition (December 2023) covers selection, verification and validation, and endpoint use. Cognitive tests are performance outcome (PerfO) assessments, where "the patient is assessed, but no rater judgment impacts the measurement."

Sources: FDA, Early Alzheimer's Disease (draft guidance); Federal Register, Mar 12, 2024; FDA DHT guidance (final, Dec 2023); Walton et al., Value Health 2015.

What it means for startups

Our reading (editorial, not from a source):

• Check whether 882.1470 fits. A battery that interprets cognitive function for clinicians likely does; many such devices are exempt, but a test aimed at diagnosing a specific disease using visual, auditory or hand inputs is not.
• Do not claim to diagnose Alzheimer's or MCI under this classification; the labeling must say the device does not diagnose.
• Plan the labeled performance data early: sensitivity, specificity, PPV, NPV, repeatability, cut-off derivation and construct validity.

Related resources

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• Wearables and neurology consulting