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Understanding PCCP for AI/ML Medical Devices: Webinar
The Need for Smarter AI/ML Regulation
The world of AI/ML-enabled medical devices is evolving rapidly, but regulatory processes often lag behind innovation. Updating an AI model in a medical device shouldn’t mean enduring a long, costly resubmission process. The FDA’s Predetermined Change Control Plans (PCCP) provide a structured way for companies to make pre-approved, controlled updates to their AI/ML software without undergoing full regulatory resubmission each time.
Orthogonal’s recent webinar, “Understanding PCCP for AI/ML Medical Devices: A Practical Guide,” explored the essentials of PCCP, how companies can leverage it to accelerate time-to-market, and what regulatory leaders need to know about compliance. Featuring insights from Brendan O’Leary, Digital Health Technology Consultant, and Megan Graham, VP of Regulatory & Quality at Orthogonal, the discussion was moderated by Bernhard Kappe, CEO & Founder of Orthogonal.
For professionals in regulatory affairs, quality assurance, or medical device development, understanding PCCP is essential to managing AI/ML updates efficiently while staying compliant.
What Is a Predetermined Change Control Plan (PCCP)?
A PCCP is a proactive regulatory strategy that allows medical device manufacturers to outline and pre-approve modifications to an AI/ML-based system. Instead of re-submitting an entirely new 510(k) or PMA every time an AI model is updated, companies can define:
- The types of AI/ML changes expected (e.g., retraining frequency, data set updates).
- Verification & validation protocols to ensure new versions meet safety and efficacy standards.
- Risk assessment & mitigation strategies to maintain regulatory compliance.
By integrating PCCP into regulatory submissions, companies can streamline updates while ensuring continued compliance with FDA guidelines.
Why PCCP Matters for AI/ML Medical Devices
Traditional regulatory pathways are built around static medical devices, which makes sense for hardware but creates unnecessary friction for AI-driven systems that continuously improve over time. The FDA’s PCCP framework bridges the gap between regulatory rigor and AI adaptability, benefiting both manufacturers and patients.
Key Benefits of PCCP:
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Faster AI/ML Model Updates
- Reduce regulatory delays for AI-driven improvements.
- Avoid prolonged review cycles that slow down patient access to innovation.
- Cost Savings in Regulatory Submissions
- Minimize the financial burden of frequent resubmissions.
- Maintain compliance without sacrificing development speed.
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Better AI Performance & Patient Outcomes
- Ensure AI/ML models continuously improve with real-world data.
- Maintain high safety and efficacy standards while adapting to new clinical insights.
By leveraging PCCP, companies can move beyond regulatory bottlenecks and focus on innovation, safety, and efficiency.
Building a Strong PCCP: What You Need to Include
Implementing a PCCP isn’t just about checking boxes—it requires careful planning and collaboration between regulatory, quality, and engineering teams. The FDA expects PCCP submissions to include the following core components:
Defining the Scope of AI/ML Changes
- Clearly outline what aspects of the AI/ML system may change over time, including:
-
- Data inputs (e.g., new training datasets)
- Algorithmic modifications (e.g., improved feature extraction methods)
- Performance metrics (e.g., sensitivity, specificity)
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Verification & Validation Processes
A PCCP must demonstrate how AI/ML updates will be tested and validated to ensure continued safety, effectiveness, and clinical relevance.
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Risk Assessment & Mitigation Strategies
- Identify potential risks of AI updates (e.g., model drift, bias introduction).
- Define controls to prevent unintended negative impacts.
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Regulatory Communication & Documentation
A well-structured PCCP should:
- Provide clear regulatory justifications for anticipated changes.
- Include robust documentation to support post-market compliance.
- Facilitate ongoing dialogue with the FDA for alignment on expectations.
Companies that take a proactive approach to these components will reduce regulatory friction and speed up innovation cycles.
Industry Insights: PCCP in Action
During the webinar, Brendan O’Leary and Megan Graham provided insights into how PCCP is already transforming AI/ML medical device regulation. Some key takeaways from real-world applications include:
- Companies using PCCP have significantly reduced regulatory submission timelines for AI-driven updates.
- Well-structured PCCPs improve collaboration between regulatory and engineering teams, leading to fewer internal conflicts and faster implementation of AI improvements.
- Early engagement with the FDA is critical for companies that work closely with regulators when drafting their PCCP experience fewer roadblocks.
These insights underscore the practical value of PCCP and its potential to reshape AI/ML medical device regulation.
Challenges & Considerations for PCCP Adoption
While PCCP provides substantial benefits, companies must be prepared to address a few key challenges:
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Balancing Regulatory Compliance & Innovation
- AI/ML updates must remain within the approved scope of the PCCP.
- Changes beyond the predefined boundaries may still require additional regulatory review.
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Cross-Functional Collaboration Is Essential
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- Regulatory teams must align with engineering and quality assurance to ensure compliance without slowing down AI development.
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Regulatory Uncertainty & Future FDA Guidance
- The FDA is continuously refining its approach to AI/ML regulation.
- Companies should stay informed on new guidance and best practices to ensure compliance.
By addressing these considerations upfront, companies can maximize the benefits of PCCP while avoiding regulatory missteps.
Key Takeaways: PCCP as a Competitive Advantage
PCCP isn’t just about regulatory compliance—it’s a strategic asset that can help MedTech companies stay ahead in the AI/ML space. Here’s why it matters:
-
Accelerate Time-to-Market
PCCP removes barriers to deploying AI/ML updates, allowing companies to roll out improvements faster than competitors still relying on traditional regulatory pathways.
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Reduce Compliance Costs
By eliminating the need for full resubmissions, PCCP significantly cuts regulatory expenses while maintaining safety and effectiveness.
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Drive Innovation While Staying FDA-Compliant
AI/ML models thrive on continuous improvement. PCCP ensures companies can iterate without regulatory delays, keeping products at the cutting edge of medical technology.
For MedTech manufacturers working on AI-driven devices, embracing PCCP is a no-brainer. Those who integrate it effectively will be able to innovate faster, lower costs, and bring safer, smarter AI-enabled medical devices to market.
Next Steps: How to Implement PCCP in Your Organization
Ready to take advantage of PCCP? Here’s what to do next:
Assess Your AI/ML Product Pipeline
Identify AI-driven devices that could benefit from a PCCP strategy.
Develop a Clear PCCP Framework
Work with regulatory, engineering, and quality teams to build a robust, FDA-aligned PCCP.
Engage Early with the FDA
Proactive communication with regulators ensures smoother approval processes and avoids unnecessary roadblocks.
Stay Updated on FDA Guidance
PCCP is evolving—staying informed will ensure ongoing compliance and continued competitive advantage.
By integrating PCCP into regulatory strategies, MedTech companies can move faster, innovate smarter, and maintain compliance with confidence.
Final Thoughts
PCCP represents a pivotal shift in AI/ML medical device regulation—one that allows companies to harness the full potential of AI without being hamstrung by slow, outdated regulatory pathways. As industry leaders embrace PCCP, those who act early will gain a distinct advantage in regulatory efficiency, product innovation, and market leadership.
If you’re in regulatory affairs, digital health, or medical device development, now is the time to explore how PCCP can transform your approach to AI/ML updates.
Speakers
Brendan O’Leary, Digital Health Technology Consultant
Brendan O’Leary provides consulting services on digital health and medical device regulatory strategy to technology developers, healthcare organizations, trade and professional associations, and other stakeholders.
Brendan worked at the FDA for 14 years in a variety of roles, most recently as the founding Deputy Director of the Digital Health Center of Excellence and as its Acting Director throughout 2022. Brendan contributed to hundreds of precedent-setting decisions and co-authored dozens of policy documents that continue to provide the foundation for the FDA’s digital health efforts. He frequently represented the FDA on digital health and other topics through presentations at conferences and professional society meetings, press interviews, and interactions with Congress. Brendan also made significant contributions to the federal government’s response to SARS-CoV-2.
Megan Graham, VP or Regulatory & Quality, Orthogonal
Megan Graham is the Vice President of Regulatory and Quality at Orthogonal, bringing over 25 years of experience in software engineering and regulatory affairs. She has worked with leading organizations like Medtronic and Mayo Clinic, and founded her own digital health consulting practice in 2015. Megan’s expertise spans healthcare AI/ML, product development, risk management, and compliance strategies. As an adjunct professor at the University of Minnesota and active member of RAPS, HIMSS, and AAMI, she remains dedicated to advancing best practices in digital health.
Moderator
Bernhard Kappe, CEO & Founder, Orthogonal
Bernhard Kappe is the Founder and CEO of Orthogonal. For over a decade, Bernhard has provided thought leadership and innovation in the fields of Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical device systems. As a leader in the MedTech industry, Bernhard has a passion for launching successful medical device software that makes a difference for providers and patients, as well as helping companies deliver more from their innovation pipelines. He’s the author of the eBook Agile in an FDA Regulated Environment and a co-author of the AAMI Consensus Report on cloud computing for medical devices. Bernhard was the founder of the Chicago Product Management Association (ChiPMA) and the Chicago Lean Startup Challenge. He earned a Bachelor’s and Masters in Mathematics from the University of Pennsylvania, and a Bachelor’s of Science and Economics from the Wharton School of Business.
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