Artificial intelligence (AI) is reshaping the medical device industry, making diagnostics, treatment planning, and patient monitoring more efficient than ever. But with innovation comes regulation. The FDA’s new AI rules for medical devices introduce critical updates that manufacturers must understand to stay compliant and competitive.
So, what’s changing? And how do these new guidelines affect your business? Let’s break it down.
Two New Guidances Released in 2025
In January 2025, the FDA released two significant draft guidance documents addressing the regulation of AI-enabled medical devices:
- Marketing Submission Recommendations for Predetermined Change Control Plans (PCCPs)
- AI-Enabled Device Software Functions: Life Cycle Management and Marketing Submission Recommendations
Together, these guidances outline how manufacturers can manage changes to AI-based medical software while staying compliant. They support both innovation and patient safety through clear regulatory expectations.
Understanding PCCPs
The PCCP guidance allows manufacturers to propose pre-approved modifications to AI software during the initial marketing submission. This flexibility reduces the need for future submissions, making AI updates faster and more efficient.
Key Changes in the PCCP Guidance
- Emphasis on PCCPs:
Manufacturers are encouraged to submit a Predetermined Change Control Plan to support future AI software changes without new regulatory hurdles. - Clear documentation requirements:
Plans should include detailed descriptions of proposed modifications, how they will be developed, validated, and their expected impact on safety and performance. - Greater focus on risk assessment: The guidance highlights the importance of identifying and mitigating risks related to evolving AI behavior.
Understanding the AI-Enabled Software Functions Guidance
The second January 2025 draft guidance provides a broader regulatory framework for AI-enabled device software functions (AI-DSFs). The guidance applies to software functions that include AI models designed to achieve a medical purpose. Here are its key areas:
- Total product lifecycle (TPLC) approach:
FDA recommends ongoing oversight from development through postmarket use. This includes documentation, validation, deployment planning, and updates.
- Marketing submissions:
The guidance outlines what’s needed to demonstrate substantial equivalence or safety and effectiveness, and encourages early FDA engagement for novel technologies.
- Focus areas:
Emphasizes risk management, data management, performance validation, and continuous monitoring. It also addresses transparency and bias mitigation, calling for design considerations that support fairness and explainability.
- Use of standards
The FDA promotes recognized consensus standards and includes examples in appendices, such as a) Model cards that explain the purpose, training data, performance, and limitations of AI models and b) 510(k) summaries with model cards to demonstrate equivalence and support transparency.
How This Impacts Medical Device Manufacturers
If you’re developing AI-powered medical devices, these new rules mean:
- Faster regulatory approval for AI updates with an approved PCCP.
- Increased accountability for performance, bias, and safety.
- More robust data and risk management expectations across the product lifecycle.
Understanding and implementing both guidances is now essential to staying competitive and compliant.
Staying Ahead with Regulatory Experts
Navigating the FDA’s new AI rules for medical devices can be complex, but you don’t have to do it alone. At Quality Smart Solutions, we support risk management, data management, and innovation planning to help keep your AI systems compliant and effective.
With AI rapidly evolving, staying on top of regulations is essential. These new FDA rules aim to balance innovation and safety, and understanding them now can save time and prevent delays down the road.
Need help navigating these changes? Contact us and fill out the form below for a free consultation. We help you ensure your AI-enabled medical devices meet FDA standards while staying ahead of the competition.
