# Regulatory Approval Is Not Enough: Gaps in Trustworthy AI Reporting in FDA-Cleared Medical Devices

arXiv: https://arxiv.org/abs/2608.12360 · HTML: https://mlsanity.com/paper/2608.12360/

## Key facts

- No citing papers in the map yet (data through 14 Oct 2026).
- Builds on 1 of its 9 references that are in the map.
- First posted on arXiv 4 Jul 2026.

## Builds on (most cited first, 1 of 1)

- [FUTURE-AI: International consensus guideline for trustworthy and deployable artificial intelligence in healthcare](https://mlsanity.com/paper/2309.12325/) (2023)

## Abstract (arXiv)

Background: AI/ML-enabled medical devices are increasingly deployed in healthcare under evolving regulatory frameworks. As these systems become more integrated into clinical decision-making, there is growing expectation that they demonstrate key dimensions of trustworthy AI to support clinician, patient, and public trust. Whether publicly available regulatory documentation provides sufficient evidence to independently assess the trustworthiness of cleared AI systems remains unclear. Methods: We analysed FDA AI/ML-enabled medical device summary reports published between 2021 and 2025. Reports underwent automated keyword screening followed by multi-stage manual consensus review to identify documented evidence for the six FUTURE-AI principles: Fairness, Universality, Traceability, Usability, Robustness, and Explainability. Descriptive, temporal, and clinical-domain analyses were performed. Multivariable logistic regression assessed whether year of clearance or clinical domain predicted higher reporting transparency, defined as evidence reported for three or more principles. Results: Of 1,105 FDA summary reports screened, 519 were included. Trustworthy AI reporting was limited and uneven. Nearly one quarter (24.7%) provided no evidence for any principle, and none documented evidence across all six. Robustness was most frequently reported (57.6%), while Traceability (8.3%) and Explainability (3.5%) were the most pronounced gaps. Neither year of clearance (OR 1.02, 95% CI 0.88-1.19) nor clinical domain (OR 0.73, 95% CI 0.46-1.15) predicted higher reporting transparency. Interpretation: Substantial, persistent trustworthy AI reporting gaps exist in FDA documentation. Regulatory approval alone should not be considered a proxy for trustworthiness. Standardised, audit-ready reporting across the AI lifecycle is needed to support independent assessment and responsible adoption of healthcare AI.