FDA’s Q-Submission Program for Medical Devices, Software-in-a-Medical Device Products & SaMD with Considerations for Using AI & ChatGPT

Overview:

The U.S. Food and Drug Administration (FDA) has taken a major step toward modernizing how medical devices—especially software-driven and high-risk innovations—are brought to market. In May 2025, the agency finalized its updated guidance on the Q-Submission (Q-Sub) Program, an evolved framework originally known as the Pre-Submission process. Though voluntary, this program has become a highly recommended pathway for companies developing complex, novel, or software-heavy medical devices—including Software as a Medical Device (SaMD) and AI/ML-powered solutions. The Q-Sub program provides structured opportunities for engaging with FDA reviewers prior to or during a regulatory submission, helping sponsors gain critical feedback, avoid missteps, and ultimately reduce time to market.

This session offers a deep dive into the Q-Sub program, covering its key components—Pre-Submissions, Study Risk Determinations, Submission Issue Meetings, Informational Sessions, and Day 100 Meetings—and how each can support product development and approval. Of particular interest to innovators is the Pre-Sub’s role in enabling feedback on Predetermined Change Control Plans (PCCPs), which allow companies to make certain post-approval modifications without submitting new applications. Understanding how to properly structure a PCCP and secure FDA buy-in can have lasting implications on product lifecycle speed, compliance, and business agility.

As part of FDA’s broader digital transformation, the session also explores the use of the eSTAR (electronic Submission Template And Resource) portal—now mandatory for most 510(k) and 513(g) submissions, and encouraged for PMA and De Novo filings. This tool is reshaping how regulatory content is structured and submitted, offering interactive templates that support both compliance and efficiency. For regulatory affairs teams, mastering eSTAR has become a vital skill as FDA steadily migrates its systems toward a more automated, data-driven model.

Beyond the mechanics of submissions, the webinar addresses the accelerating integration of Artificial Intelligence (AI), Machine Learning (ML), and Large Language Models (LLMs) like ChatGPT into both the products being submitted and the internal systems FDA uses to review them. With the Valid Act currently under consideration in Congress, the agency is preparing for a "firm-based" regulatory model—evaluating a manufacturer’s development processes, validation methods, and internal safeguards rather than attempting to fully deconstruct how AI/ML tools function. This evolution creates both opportunity and risk: companies must now ensure their tools are transparent, well-documented, and aligned with new and forthcoming FDA expectations.

Attendees will also gain clarity on how AI and LLMs are already being deployed within the FDA’s own operations to eliminate review bottlenecks and enable more nuanced risk assessment. The agency's internal mandate to adopt generative AI across all Centers signals a radical shift in how reviews are prioritized and executed. As FDA increasingly focuses its human reviewers on edge cases and high-risk technologies, manufacturers that present clean, high-quality submissions through Q-Sub and eSTAR channels will be better positioned to benefit from faster, more focused engagement.

This webinar brings together regulatory intelligence, submission strategy, and forward-looking insights for professionals working at the intersection of software, compliance, and innovation. Whether you're preparing your first SaMD submission, managing lifecycle changes to an existing device, or developing AI-powered tools in the life sciences space, this session will prepare you for what’s next in FDA regulation—and how to meet it with confidence.

Areas covered in the session:

During the webinar, we will discuss the following:

• Learn about FDA’s Q-Submission program for all medical device products.
• Learn how to use the Q-Sub program to facilitate meetings and discussions with FDA for early feedback to gain an advantage in device development and submission.
• Understand the components of the Q-Sub program, including what FDA expects in terms of contact, questions, issues and meetings.
• Understand how the eSTAR program and FDA’s submission portal can be used to submit an application using interactive templates that can simplify the Q-Submission Process.
• Learn about how use of Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT are all increasingly being used in the life science industries, and how companies are leading the way to delivering more effective, safer, and more beneficial products as a result.
• Learn how FDA is incorporating AI, ML and ChatGPT into their submission review process to accelerate the timeline, which will bring products to market faster.
• Learn about the potential risks and challenges related to AI, ML and LLMs, such as ChatGPT.
• Understand how FDA, Congress, technology developers, and the health care industry must work together to forge this new path forward and lead to a deeper and broader application of AI in operational processes in today’s FDA-regulated companies.
• Understand current industry best practices and recommendations for using the Q-Submission process and for improving compliance of products that leverage AI, ML and ChatGPT in operational processes.
• Q&A

Handouts:

Attendees will gain access to exclusive handouts, including presentation materials provided by the speaker and additional resources developed by Amorit Education to aid your teams in post-session implementation.

Why Should You Attend?

If you're involved in the development, validation, or regulatory submission of medical devices—especially software-driven products or AI/ML-powered tools—this session will help you stay ahead of rapidly changing FDA expectations.

The FDA’s finalized Q-Submission guidance, the expanding use of eSTAR, and the agency’s own integration of AI and LLMs like ChatGPT are reshaping how companies prepare and submit device applications. This webinar offers you a practical roadmap for navigating these shifts, reducing costly back-and-forths, and accelerating your product’s path to market.

You'll gain clear, actionable insight into how to engage FDA early through Pre-Subs, how to craft PCCPs for post-market flexibility, and how the eSTAR portal fits into the larger Q-Sub strategy. For companies leveraging AI, you’ll also learn how the Software Validation and Maintenance process must evolve to meet today’s digital compliance demands—along with how FDA is regulating (and using) tools like ChatGPT internally to streamline reviews.

This session isn’t just about learning a new process—it’s about future-proofing your submission strategy, embracing compliance innovations, and understanding how AI is transforming both industry and agency alike.

Who will benefit?

This webinar is intended for those involved in planning, execution and support of medical device design, development and testing activities, whether it is a traditional device with hardware only, or works with a software component, or finally, is an SaMD product, functioning as a medical device without the aid of any hardware. Anyone working in the FDA-regulated industries, including

• Information Technology Analysts
• Information Technology Developers and Testers
• Software Companies Developing Medical Device Software and/or Software-as-a-Medical-Device (SaMD)
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts and Managers
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance. It will also help those in software development companies who support the life science industries.