---
kind: "section"
citation: "21 C.F.R. § 882.1491"
title: "21"
number: "882.1491"
heading: "Pediatric Autism Spectrum Disorder diagnosis aid."
url: "https://uscodex.org/cfr/21/882.1491"
---

# §882.1491. Pediatric Autism Spectrum Disorder diagnosis aid.

- (a) **Identification.** A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of sensitivity, specificity, positive predictive value, and negative predictive value using a reference method of diagnosis and assessment of patient behavioral symptomology.
  - (2) Software verification, validation, and hazard analysis must be provided. Software documentation must include a detailed, technical description of the algorithm(s) used to generate device output(s), and a cybersecurity assessment of the impact of threats and vulnerabilities on device functionality and user(s).
  - (3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
  - (4) Labeling must include:
    - (i) Instructions for use, including a detailed description of the device, compatibility information, and information to facilitate clinical interpretation of all device outputs; and
    - (ii) A summary of any clinical testing conducted to demonstrate how the device functions as an interpretation of patient behavioral symptomology associated with Autism Spectrum Disorder. The summary must include the following:
      - (A) A description of each device output and clinical interpretation;
      - (B) Any performance measures, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV);
      - (C) A description of how the cutoff values used for categorical classification of diagnoses were determined; and
      - (D) **Any expected or observed adverse events and complications.**
    - (iii) **A statement that the device is not intended for use as a stand-alone diagnostic.**

## Notes

### Amendments

[87 FR 80445, Dec. 30, 2022]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

### Amendments

[87 FR 80445, Dec. 30, 2022]