FDA AI Guidance for Medical Devices: A Practical Guide

Navigating FDA AI Guidance for Medical Devices: A Practical Guide

For medical device professionals, the integration of Artificial Intelligence (AI) and Machine Learning (ML) represents a monumental leap forward in innovation. However, this progress comes with significant regulatory hurdles. As AI algorithms evolve, so do the rules that govern them, leaving many development, quality, and regulatory teams struggling to keep pace. Failing to understand and adapt to the latest FDA AI guidance can lead to submission delays, compliance issues, and costly rework.

This guide delivers a practical overview of the evolving FDA regulatory framework for AI and ML-based medical devices, drawing on both recent draft guidance and the agency’s longer-term action plans. We highlight essential concepts including the Predetermined Change Control Plan (PCCP), Good Machine Learning Practices (GMLP), and Real-World Performance (RWP) monitoring and show how these shape the compliance landscape for manufacturers.

TL;DR: The FDA is moving toward a holistic Total Product Lifecycle (TPLC) regulatory approach for AI/ML-enabled medical devices, emphasizing continuous monitoring, clear GMLP, and mechanisms for pre-planned algorithm updates. Robust, traceable documentation, and proactive lifecycle risk management are now essential for compliance and product success.

The FDA’s Evolving AI/ML Regulatory Framework

The FDA has signaled its commitment to adapting device oversight in response to rapid advances in AI/ML. Traditionally, regulatory submissions were point-in-time events. Now, regulators recognize that adaptive, learning systems require ongoing oversight, especially as software “learns” from real-world experience.

Key foundational documents illustrate this evolution:

FDA’s 2021 AI/ML-Based Software as a Medical Device (SaMD) Action Plan: This action plan lays out five pillars to modernize oversight including development of a tailored regulatory framework, advancement of GMLP, fostering transparency with users, promoting methodologies for bias/robustness, and supporting real-world performance pilots.
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft Guidance, 2025): This draft guidance details expectations for managing AI within medical devices throughout the entire product lifecycle, including design, labeling, bias mitigation, cybersecurity, postmarket surveillance, and the importance of the Predetermined Change Control Plan.
Clinical Decision Support Software Guidance (2026): Clarifies FDA’s criteria for Clinical Decision Support (CDS) software functions, offering practical examples to distinguish between Non-Device CDS such as software functions excluded from device regulation and those that remain under device oversight.
FDA AI/ML-Enabled Medical Devices List: Provides a current catalog of FDA-authorized devices using AI/ML technologies, helping manufacturers benchmark their projects and understand regulatory precedent.
General Wellness: Policy for Low-Risk Devices: Clarifies what qualifies as a low-risk wellness device or feature and what falls outside medical device oversight.

In summary: The FDA’s approach now encompasses both initial submissions and ongoing, risk-based management, aligning regulatory expectations with the unique characteristics of AI/ML-driven technologies.

RELATED: The Evolution of FDA Design Controls (21 CFR 820.30) and How Jama Software Supports Compliance

Core Concepts in the FDA’s AI/ML Oversight

1. Predetermined Change Control Plans (PCCP)

Introduced in both the 2021 action plan and expanded in the draft 2025 guidance, a PCCP enables manufacturers to define anticipated modifications to an AI/ML algorithm upfront. The plan specifies “what” may be changed (pre-specifications) and “how” changes are managed (an algorithm change protocol). This approach recognizes the evolving nature of AI/ML models, especially those learning from real-world use.

2. Good Machine Learning Practices (GMLP)

The FDA calls for GMLP, which are best practices covering data management, training procedures, documentation, interpretability, and bias mitigation, all aligned with consensus standards. GMLP underpins both product quality and regulator confidence, reducing the risk of unexpected outcomes or patient harm (See Action Plan Pillar 2).

3. Transparency and User Trust

Both guidance documents emphasize transparency for end users including clinicians, patients, and caregivers. Clear labeling, robust documentation, and transparency about model logic, data sources, and limitations are expected to build trust in AI/ML-powered devices.

4. Real-World Performance (RWP) Monitoring

Unlike static software devices, AI/ML-based products must demonstrate ongoing safety and efficacy. The FDA encourages collection and review of real-world data as part of postmarket surveillance. Manufacturers should implement plans for ongoing performance monitoring by adapting both processes and documentation to ensure device quality over time.

5. Bias Mitigation and Robustness

AI/ML algorithms can inadvertently encode biases from historical datasets. The FDA expects proactive identification and management of bias through diverse, representative training data, ongoing performance validation, and transparent reporting on limitations and subgroup analysis.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

Practical Strategies for AI/ML Medical Device Teams

Step 1: Build a TPLC-Ready Development Program

Map your design and postmarket processes to the FDA’s TPLC vision. Reference both the 2025 draft guidance and the 2021 action plan to ensure full coverage.

Step 2: Document Everything—and Connect the Dots

Your design history, risk management, GMLP adherence, model versions, data sets, and algorithm updates should all be auditable and linked. Use digital solutions for traceability and compliance, making audit preparation seamless.

Step 3: Prepare and Maintain a PCCP

If your product uses adaptive algorithms, develop a comprehensive Predetermined Change Control Plan. Detail the types of future modifications, associated risk controls, and your process for validating postmarket changes.

Step 4: Embrace Ongoing RWP Monitoring

Postmarket surveillance now means real-world performance tracking including collecting user feedback, monitoring for data drift, bias, and managing field updates in a proactive, traceable way.

Step 5: Differentiate Wellness from Medical Claims

Consult the Wellness Policy to determine if any features of your device are exempt from device regulation and document your rationale.

Frequently Asked Questions

Q: What’s the difference between Software as a Medical Device (SaMD) and AI in Medical Devices (AiMD)?
A: SaMD refers to software that is itself a medical device. AiMD is software that is integrated into a physical device. Both fall under the FDA’s AI/ML regulatory frameworks.

Q: Is a PCCP mandatory for all AI-enabled devices?
A: PCCPs are expected for devices with adaptive/evolving algorithms. Rigid, non-learning AI products may not need a PCCP, but processes for documenting and justifying updates are still required (draft guidance, 2025).

Q: How should we implement GMLP?
A: Follow best practices outlined by the FDA and consensus standards. Ensure your team manages data, training processes, versioning, and labeling in a repeatable, controlled, and demonstrable manner.

Master the Complexity of AI Medical Device Development

The regulatory landscape for AI medical devices is complex, but it shouldn’t stifle innovation. By adopting an integrated approach with a live digital thread, you can manage the intricate web of requirements, risks, and data that define modern device development. This not only prepares you to pass audits with confidence but also empowers your teams to build safer, more effective products faster.

Jama Connect^®, enhanced with AI-powered features in Jama Connect Advisor™, provides the end-to-end traceability needed to manage the development of complex AI-enabled systems. Streamline your documentation, automate traceability, and ensure your team is always audit-ready.

Ready to see how you can transform your product development process? Schedule a personalized demo to learn more about Jama Connect.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Tom Rish.

Author
Recent Posts

Tom Rish

Senior Product Marketing Manager at Jama Software

Tom Rish is a biomedical engineer with over 15 years of experience developing medical devices. His work has spanned the entire MedTech product lifecycle, from initial concept through market launch. He is passionate about helping others navigate the complex journey of bringing a device to market so that patients around the world can benefit from life-changing technologies. Tom is currently a member of the Product Marketing team at Jama Software.