> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Learn from Exer Labs Warning on AI Use: Attorneys
- URL: https://www.fdaweb.com/learn-from-exer-labs-warning-on-ai-use-attorneys/
- Published: 2025-04-29T12:00:00.000Z
- Updated: 2026-09-14T15:10:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159087

Attorneys **Melissa Bianchi** and **Jodi Scott** (Hogan Lovells) say medical device companies can learn from a recent FDA [Warning Letter](https://www.fdaweb.com/exer-labs-illegally-marketing-exer-scan-fda/) to Exer Labs citing a failure to obtain PMA or 510(k) clearance for its Exer Scan mobile AI-based screening tool. The letter also cited good manufacturing practice violations for an artificial intelligence (AI)-enabled medical device.

“In the letter,” the attorneys write in an online [post](https://www.lexology.com/library/detail.aspx?g=0220ac53-88be-418b-ac7e-6e926a66eb06&ref=fdaweb.com), “FDA provides instructive clarification of its views of the limitation of the 510(k) exemption claimed by the company and also identifies quality management system gaps indicative of a company that has not developed significant portions of the quality management system that is required for most medical devices even if exempt from premarket reporting requirements. The Warning Letter is a cautionary tale for companies developing software and AI-based applications that screen, diagnose, and treat diseases and the potential for enforcement action where classification is incorrect and quality compliance infrastructure is not adequately developed.”

They also say the letter can be instructive and an indication of FDA priorities for AI governance to apply its existing frameworks, as it highlights the need for written procedures for design controls, handling complaints, and corrective actions in response to quality problems. “For companies focusing on device cases and seeking a programmatic approach for compliance,” they say, “the Warning Letter calls out specific areas that should be integrated as company policies, including ensuring suppliers are qualified, adequate training on the system and updates, management review, and audits.”