The FDA is updating 21 CFR Part 820 with a new approach, Quality Management System Regulation (QMSR) in February 2026. This transition is a significant update to medical device quality requirements for medical device manufacturers.  

What are the changes to FDA 21 CFR 820?

The new regulation harmonizes FDA requirements with ISO 13485:2016, the international standard for medical device quality management systems. This alignment means companies operating globally will no longer need to maintain separate quality systems for US and international markets.

Key changes include: ‍

• ‍Risk-based approach: Greater emphasis on risk management throughout the product lifecycle ‍
• Updated terminology: Modern language that reflects current industry practices ‍
• Enhanced documentation requirements: More explicit expectations around electronic records and quality system documentation
• ‍Supplier management: Strengthened requirements for managing and monitoring suppliers

Timeline and Compliance Requirements

Manufacturers have until February 2, 2026 to bring their quality systems into compliance with the new regulation. Implementing comprehensive QMS changes often takes 12-18 months, so companies need to be transitioning quickly.

The FDA expects companies to demonstrate not just compliance on paper, but evidence that new processes are functioning effectively. This means your team needs time for both implementation of changes and documentation to prove your system works.

Strategic Considerations for Your Company

1. Gap Analysis Should Start Today

If your current QMS is based solely on 21 CFR 820 without ISO 13485 alignment, you'll face more substantial changes. Companies already operating under ISO 13485 will find the transition smoother, but gaps still exist between the international standard and FDA expectations.

2. Resource Allocation

This transition will require dedicated resources—both personnel time and potentially technology investments. Companies need to assess:

• Current quality team capacity
• Need for additional training or expertise
• Software or system upgrades required for compliance
• Documentation review and update timelines

3. Integration with Product Development Timelines

For companies actively developing new products or pursuing FDA submissions, the QMS transition must be carefully coordinated with:

• Ongoing clinical trials
• Planned regulatory submissions (510(k), De Novo, PMA)
• Product launches and commercialization timelines

Waiting to address compliance could jeopardize submission timelines or create complications during FDA audits.

4. Supplier and Contract Manufacturer Implications

If you work with contract manufacturers or critical suppliers, their compliance timelines matter to you. Ensure your partners are planning their transitions appropriately and understand how changes might affect your supply chain or manufacturing arrangements.

Why This Matters for AI/ML Medical Device Companies

For companies developing AI-powered medical devices, this transition carries additional weight. The new regulation's emphasis on risk management and lifecycle monitoring aligns closely with FDA's evolving expectations for AI/ML devices, including:

• Algorithm change protocols
• Post-market performance monitoring
• Predetermined change control plans

Getting your QMS foundation right now positions your company to navigate AI-specific regulatory requirements more effectively.

Work with Experts

At Proxima Clinical Research, we're helping medical device companies navigate this transition strategically. Our regulatory and quality affairs team brings deep expertise in both 21 CFR 820 and ISO 13485, with particular strength in helping emerging companies build quality systems that satisfy regulatory requirements without creating unnecessary operational burden.

We work with you to:

• Conduct comprehensive gap analyses against the new requirements
• Develop practical implementation roadmaps aligned with your business priorities
• Create or update quality system documentation
• Prepare for FDA inspections under the new regulation
• Integrate QMS updates with ongoing regulatory submissions and clinical programs

Companies struggling to plan for this transition or navigate the new regulatory landscape with confidence and a competitive advantage should work with a trusted partner like Proxima.  

Ready to Start Planning?

If you're uncertain about your compliance timeline, need support conducting a gap analysis, or want strategic guidance on managing this transition alongside your product development goals, Proxima can help.

Contact us today to discuss your quality management system transition and ensure you're positioned for success under the new regulation.

About Proxima:

Proxima CRO delivers specialized regulatory, quality, and clinical trial support for medical device and biotech companies—particularly those developing AI-powered technologies. We provide the service you need, the speed you want, and the attention you deserve.