FDA Pre-Submission (Q-Sub) Support || Tacit MedTek

Medical Device Services

Quick Snapshot

Service – FDA Pre-Submission (Q-Sub) Support
Who Can Apply?
- Medical Device Manufacturers
- IVD Manufacturers
- Software as a Medical Device (SaMD) Developers
- AI/ML Medical Device Developers
- Domestic Manufacturers
- Foreign Manufacturers
Services Covered
- Regulatory Pathway Assessment
- FDA Q-Sub Strategy Development
- Question Drafting
- Meeting Package Preparation
- FDA Meeting Support
- Feedback Review and Action Planning
Typical Discussion Topics
- Device Classification
- Regulatory Pathway Selection
- Performance Testing
- Clinical Evaluation
- Software Documentation
- Cybersecurity
- Human Factors / Usability
- Risk Management
Timeline – FDA generally provides feedback within established Q-Submission review timelines. Actual timelines may vary depending on the type and complexity of the request.
FDA Fee – FDA currently does not charge a user fee for standard Pre-Submission (Q-Sub) requests.

What is FDA Pre-Submission (Q-Sub) Support

The FDA Pre-Submission (Q-Sub) program provides an opportunity for medical device manufacturers to obtain feedback from the U.S. Food and Drug Administration (FDA) before making a formal regulatory submission such as a 510(k), De Novo Request, PMA, or IDE application.

Through the Q-Sub process, manufacturers can discuss topics such as device classification, regulatory pathways, performance testing, clinical study plans, software documentation, cybersecurity requirements, and other regulatory expectations with the FDA.

Obtaining FDA feedback at an early stage can help manufacturers better understand regulatory requirements, identify potential gaps, and prepare a more informed submission strategy before investing significant time and resources in product development and testing.

FDA Q-Submission Support

When Do You Need Q-Submission Support?

Strategic support for obtaining early FDA feedback on regulatory pathways, clinical evidence, testing plans, software, cybersecurity, and innovative medical devices.

When Do You Need Q-Submission Support?

Developing a novel or innovative medical device
When the regulatory pathway is unclear
When FDA feedback is required before a 510(k), De Novo, PMA, or IDE submission
When clinical study requirements need clarification
When input is required on performance testing or validation plans
When predicate device selection is uncertain
When the device includes software, AI, machine learning, or cybersecurity features
When significant technological differences exist compared to marketed devices
When you want to discuss risk management or usability testing approaches with FDA
When early regulatory feedback could support product development planning

Key Challenges

Determining the most appropriate regulatory pathway
Understanding FDA expectations for testing and validation
Preparing focused and meaningful questions for FDA review
Identifying the right level of supporting information
Aligning development activities with FDA guidance documents
Defining clinical evidence requirements
Addressing software and cybersecurity expectations
Preparing effective meeting packages and presentation materials
Interpreting FDA feedback and implementing recommendations

Our Approach and What You Will Get

Structured support to obtain meaningful FDA feedback and translate it into a clear strategy for future regulatory submissions.

Our Approach

Review of device technology, intended use, and development status
Regulatory pathway assessment
Identification of key topics requiring FDA feedback
Preparation of Q-Sub questions and supporting documentation
Development of FDA meeting packages and briefing materials
Support for meeting preparation and discussion planning
Review and interpretation of FDA feedback
Guidance on next steps following FDA interaction

What You Will Get (Deliverables)

Regulatory pathway assessment report
FDA Q-Sub strategy and question development
Q-Submission package preparation
Device description and intended use review
Predicate assessment support, where applicable
Testing and validation strategy review
Clinical study discussion support
FDA meeting agenda and presentation materials
Meeting preparation and rehearsal support
FDA feedback summary report
Post-meeting action plan and recommendations
Submission readiness assessment

Why Choose Tacit Medtek and Case Example

Practical support for FDA regulatory planning, Q-Sub preparation, software-enabled medical technologies, and submission readiness.

Why Choose Tacit Medtek

Understanding of FDA medical device regulatory pathways
Experience supporting regulatory planning activities for medical devices and IVDs
Practical guidance on testing, validation, and documentation strategies
Support for software-enabled and AI-based medical technologies
Structured approach to FDA interactions and meeting preparation
Assistance from regulatory planning through submission readiness
Focus on practical, compliance-oriented solutions
Dedicated support throughout the Q-Sub process

Case Example

Challenge: A company developing an AI-based radiology software device was uncertain whether the product qualified for a 510(k) or De Novo pathway. The manufacturer also needed FDA clarification regarding clinical performance validation, software documentation, and cybersecurity requirements.
Our Approach: Prepared an FDA Pre-Submission (Q-Sub) package containing detailed device information, intended use, software overview, proposed validation strategy, and focused regulatory questions. Our team also supported FDA meeting preparation and documentation review.
Outcome: The FDA provided guidance on the appropriate regulatory pathway, recommended validation approach, and software documentation expectations, enabling the company to proceed with a clearer regulatory strategy and reduced submission risk.

FAQ

Frequently Asked Questions

What is an FDA Pre-Submission (Q-Sub)?

A Q-Sub is a formal mechanism that allows manufacturers to request FDA feedback before making a regulatory submission such as a 510(k), De Novo Request, PMA, or IDE application.

Is FDA feedback received through a Q-Sub legally binding?

No. FDA feedback provided through a Q-Sub is generally non-binding but offers valuable regulatory insight that can support future submission planning.

Can clinical study plans be discussed during a Q-Sub?

Yes. Manufacturers commonly seek FDA feedback on proposed clinical protocols, study endpoints, patient populations, and statistical approaches.

Can software and cybersecurity topics be reviewed in a Q-Sub?

Yes. FDA may provide feedback on software documentation, cybersecurity controls, validation strategies, risk management activities, and testing plans.

Is testing data required before submitting a Q-Sub?

Not always. Depending on the purpose of the meeting, proposed testing plans or preliminary data may be sufficient.

Can a Q-Sub help determine whether a clinical study is required?

Yes. Many manufacturers use the Q-Sub process to obtain FDA feedback regarding clinical evidence requirements before initiating studies.

Can foreign manufacturers use the Q-Sub process?

Yes. Both U.S. and international manufacturers may request FDA feedback through the Q-Sub program.

Does every medical device require a Q-Sub?

No. Many devices proceed directly to regulatory submission. A Q-Sub is particularly useful when regulatory expectations are unclear or when novel technologies are involved.

Can I request a meeting with FDA through a Q-Sub?

Yes. Depending on the nature of the questions, manufacturers may request written feedback, virtual meetings, or in-person discussions with FDA.

What is the difference between a Q-Sub and a 510(k)?

A Q-Sub is a mechanism for obtaining FDA feedback before submission, while a 510(k) is a formal regulatory submission seeking marketing clearance for a medical device.

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