CAHIR

Guidance & Resources

Features

FDA's Digital Health Device Lists: Why the September 2026

Update Matters

A stakeholder briefing on the AI/ML, AR/VR, and sensor-based digital health technology (sDHT) device lists

The FDA has refreshed three companion resources that catalog medical devices authorized for marketing in the

United States that incorporate digital health technology: the AI/ML-Enabled Medical Device List, the Augmented

Reality and Virtual Reality (AR/VR) Medical Device List, and the Sensor-Based Digital Health Technology

(sDHT) Medical Device List, all maintained by the Digital Health Center of Excellence (DHCoE). Together, these lists

give founders, investors, health systems, and regulatory teams a rare, continuously updated public window into what

technology profiles the FDA is actually clearing, which product codes and clinical panels dominate, and how quickly a

given category is scaling. For a market-access and regulatory strategy practice, these lists are less a curiosity than a

live competitive-intelligence and benchmarking feed.

Updated September 2026

Features

AI & Digital Health In MedTech: Navigating the fDA Regulatory Landscape

Frameworks, Compliance Strategies, and Competitive Differentiators

for AI/ML Enabled Medical Devices

This report synthesizes the most consequential regulatory developments affecting AI-driven MedTech, drawing on perspectives from regulatory strategy, FDA engagement, industry product leadership, and risk and compliance disciplines. It is designed for senior MedTech executives, investors, innovators, and digital health leaders who require actionable intelligence on how the FDA’s evolving AI frameworks will shape innovation, regulatory risk, and competitive advantage.

Central Thesis: The FDA’s regulatory posture has shifted from static, one-time device approvals to a Total Product Lifecycle (TPLC) oversight model for AI-enabled devices. Companies that embed lifecycle thinking into their design, quality, and regulatory systems now will capture first-mover advantages in market access, FDA engagement, and stakeholder trust.

Report length: 17 pages / 20+ cited sources

Updated March 2026

Features

Predetermined Change Control Plans (PCCPs)

A Comprehensive Readiness Checklist for AI-Enabled Medical Device Manufacturers

In August 2025, the FDA finalized guidance on Predetermined Change Control Plans (PCCPs) tailored to

AI-enabled devices. A PCCP, submitted as part of the initial marketing authorization (510(k), De Novo, or

PMA), describes planned modifications to the device algorithm, the methodology for developing,

validating, and implementing those modifications, and an assessment of their impact. When approved,

the PCCP allows manufacturers to implement specified changes without filing a new premarket

submission for each modification.

A PCCP includes three core components: (1) Description of Modifications — what changes will be made; (2) Modification Protocol — how changes will be developed, validated, and implemented; and (3) Impact Assessment — the evaluation of benefits and risks. Each modification described in the PCCP must maintain the device’s intended use and provide reasonable assurance of continued safety and effectiveness.

This checklist is designed for MedTech executives, regulatory affairs professionals, quality engineers, and AI/ML

development teams preparing to develop or include a PCCP in a marketing submission. Use it to systematically

assess your organization’s readiness across every dimension of PCCP development and compliance.