FDA's Q-Submission Program for Medical Devices, SiMD / SaMD with Considerations for Using AI and ChatGPT

Providing safe and effective medical devices is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products. You will learn about the Q-Submission program providing industry with pathways for engaging FDA early for feedback to aid in product development.

We will cover all of the components of the Q-Submission program, including the requests for various types of meetings and letters to gain insight into the FDA’s current thinking on the subject. We will describe the eSTAR program, accessed through the FDA’s portal and integrated with the Q-Submission to facilitate the process.

With newer technologies such as AI in the mix, it means opportunity for greater efficiency and efficacy, but also poses more challenges for companies that develop, test, and support software applications in the life science industries.

In this webinar, you will learn just how AI, ML and LLMs, such as ChatGPT can increase efficiency and effectiveness of software development life cycle (SDLC) activities, enabling the delivery and support of computer solutions and new innovative products that will drive industry over the coming years. We will discuss the Software Validation and Maintenance process for ensuring these technologies are developed and managed appropriately.

You will learn how FDA is taking advantage of AI, ML and LLMs, such as ChatGPT throughout the submission and review process to shorten the timeframe and bring innovative products to market more quickly.

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco.  Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. Learn by reviewing industry best practices and knowing where to gather key information to help you move forward with these technologies quickly and in compliance with FDA.

AREAS COVERED:

• 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.

WHO SHOULD ATTEND:

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 pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.) should take advantage of this webinar. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance. Examples of who will benefit from this webinar include:

• 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.

TOPIC BACKGROUND:

Along with FDA, industry’s goals are to provide safe and effective medical devices. Recognizing the growing use of these products, FDA is working to adapt the traditional regulatory processes for use with these new, innovative products, including regulatory submissions.

The result is the Q-Submission (Q-Sub) program (previously called the Pre-Submission or Pre-Sub process) to automate the regulatory submission process for medical device products. The program applies to any medical device type regulated by CDRH, including Software-as-a-Medical Device (SaMD) products that function like a medical device without being attached to any hardware, and devices with software components.

The final guidance was issued in May 2025 and the process is voluntary. The purpose is to provide an overview of the mechanisms available to submitters through which they can seek interaction with FDA related to medical device submissions, either in the form of a written request with specific questions or a request for a meeting, via teleconference or in person. The effort is a significant step in the right direction for streamlining the process. Although a voluntary program, it is highly recommended for novel, complex and high-risk products, as well as SaMD and AI/ML-based products. Using the Q-Submission process does not guarantee approval, but it can prevent costly missteps and reduce review cycles.

The Q-Submission program consists of:

• Pre-Submission Program
• Submission Issue Meetings
• Study Risk Determinations
• Formal Early Collaboration Meetings
• Informational Meetings
• Day 100 Meeting Request

The Pre-Submission Program will likely improve the quality of subsequent submissions, shorten review times and facilitate the development process for new devices. The Pre-Subs are highly recommended for obtaining FDA feedback on development of a Predetermined Change Control Plan (PCCP) prior to including it in a premarket submission. This is critical for industry to understand how they can make changes to a device within the bounds of the PCCP following FDA authorization. A supplemental premarket approval application or a new premarket notification is not required for a change to a previously approved or cleared device if the change is consistent with the PCCP.

The Submission Issue Request (SIR) is intended to facilitate interaction between FDA and the submitter to address questions about issues identified in the letter so that projects can move forward and submitters are able to fully address outstanding questions and issues in their formal responses.

A Study Risk Determination is a request for FDA determination for whether a planned medical device clinical investigation is significant risk (SR), nonsignificant risk (NSR) or exempt from most requirements under the Investigational Device Exemption (IDE) regulations. For studies that are not exempt, sponsors must make the initial risk determination (SR or NSR) and present it to the Institutional Review Board (IRB).

An Informational Meeting is a request to share information with FDA without the expectation of feedback. This can be helpful in providing an overview of the ongoing device development and familiarizing the FDA review team about new device(s) with significant differences in technology from currently available devices.

The Day 100 Meeting is to discuss the review status of a PMA application. FDA will identify any deficiencies within 90 days from the PMA filing date or 10 days prior to any Day 100 meeting. It can be scheduled later, for example, if both the FDA and applicant concur.

For combination products, a Q-Submission should only be submitted for device-led combination products assigned to Center for Devices & Radiological Health (CDRH).

If submitters are unsure if a request should be submitted under the Q-Sub program, it is recommended that they contact the review division or OPEQ Submission Support (OPEQSubmissionSupport@fda.hhs.gov) to discuss the best pathway for the request.

During the session, we will walk through the electronic Submission Template And Resource (eSTAR) automated Q-Submission process, and discuss the requirements for submissions of medical devices. Submission using eSTAR is mandatory for most 510(k) submissions as of 10/1/2023, optional but encouraged for De Novo and PMA submissions, mandatory for 513(g) requests starting 10/1/2024, and mandatory for SaMD products submitted via a 510(k). We will discuss the Software Validation and Maintenance steps required for a premarket submission of an SaMD or medical device with software product. Examples will be highlighted of the various forms and content to be used.

The medical device industry continues to embrace new technology to improve delivery of quality products in compliance with FDA. Many are making use of cloud services, Software-as-a-Service (SaaS) solutions, Artificial Intelligence (AI), Machine Learning (ML), Large Language Models (LLMs), such as ChatGPT, and other technical innovations that have more recently begun to be used more heavily in life science companies.

We will discuss the use of AI and ML in SaMDs and devices with software, including specific requirements and advice on the approach and industry best practice recommendations. There is a great deal of work to be done by both FDA and industry in this area, but the results will be impressive.

FDA is currently modernizing their own systems and use of data. They announced that all agency’s centers had to fully integrate generative AI into work by the end of June 2025. The intent is to reduce non-productive busy-work that has historically consumed the review process. Review of product submissions can often take many months, but there is an opportunity to allow expert reviewers to focus on the more complex cases, reducing the process timeline considerably.

Rapid cycles of innovation inherent in products due to constant modification based on new information available pose challenges. ChatGPT from OpenAI has demonstrated substantial semantic medical knowledge and the ability to perform work that will accelerate the submission approval process.

Large Language Models (LLMs), such as ChatGPT trained on vast datasets embody the ultimate black box in the realm of FDA regulation. They are nonlinear and high-dimensional, making it difficult to trace specific inputs to outputs. A risk is they may return wrong answers when trained on unreliable datasets. Under a firm-based regulation approach by FDA, innovators can bring certain new products to market more efficiently with quality and compliance

The Verifying Accurate Leading-Edge Development Act, or Valid Act is pending in the US Congress, and will codify the “firm-based” approach to regulation for software products using AI, ML and LLMs, such as ChatGPT. FDA will oversee methods used for technology development and validate their reliability rather than decoupling the AI product’s construction. By ensuring robust systems are in place, FDA can enhance overall safety and effectiveness of medical devices produced.

In addition to the webinar, we will provide an appendix to the slides with references related to the Q-Submission Program, AI, Software Development Standards, Risk Management Standards,  FDA Guidance, FDA AI/ML-Driven SaMD Publications and ChatGPT.

Finally, we will provide an overview of the Software Validation and Maintenance approach that will bring clarity to what FDA is looking for in terms of assurance that products will be safe and effective.

Course Director: CAROLYN TROIANO

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.