FDA Medical Device Pre-Submissions
FDA Pre-Submission (Pre-Sub) Services for Medical Devices and IVDs
Medical device and IVD manufacturers developing products for the United States can engage with the U.S. Food and Drug Administration (FDA) before making a formal regulatory submission through the FDA’s Q-Submission Program.
An FDA Pre-Submission (Pre-Sub) provides manufacturers with an opportunity to obtain FDA feedback on specific regulatory questions before progressing with activities such as performance testing, clinical studies, predicate selection or preparation of a future 510(k), De Novo or other premarket submission.
A well-planned Pre-Submission can help identify regulatory expectations early, reduce uncertainty and provide valuable FDA feedback on areas such as regulatory strategy, testing protocols, clinical evidence, software documentation, biocompatibility, performance studies and other device-specific requirements.
Patient Guard provides expert FDA Pre-Submission services for medical devices and IVDs, supporting manufacturers with Pre-Sub strategy, preparation of questions, supporting documentation and development of a clear and structured submission package.
We help manufacturers focus their Pre-Submission on the issues where FDA feedback can provide the greatest regulatory value, ensuring questions are specific, appropriately supported and aligned with the planned U.S. market access pathway.
Whether you are developing a new medical device or IVD, planning a future 510(k) or De Novo submission, or need FDA feedback before committing to significant testing or clinical activities, Patient Guard can help you use the Pre-Submission process to establish a clearer and more informed route towards U.S. market access.
Why Choose Patient Guard for FDA Pre-Submission Support?
Strategic FDA Engagement
We help identify the regulatory questions where early FDA feedback can provide the greatest value and reduce uncertainty before your formal submission.
Focused Pre-Sub Questions
We develop clear, specific and well-supported questions designed to obtain meaningful FDA feedback on the issues that matter most to your development programme.
Regulatory Pathway Clarity
We help you seek FDA feedback on classification, regulatory pathways, predicate strategy and other key considerations before significant resources are committed.
Testing & Evidence Strategy
We support discussions with the FDA around proposed performance testing, clinical evidence, biocompatibility, software, usability and other device-specific evidence requirements.
Structured Pre-Sub Package
We prepare and review a clear, focused Pre-Submission package that provides the FDA with the background information needed to understand your device and regulatory questions.
FDA Meeting Support
We help you prepare for FDA interaction, understand the feedback received and translate it into practical next steps for your development and U.S. regulatory strategy.
What Our FDA Pre-Submission Service Includes
Regulatory Strategy Review
Reviewing your device or IVD, intended use, development stage and proposed U.S. regulatory pathway to identify the areas where FDA feedback would provide the greatest value.
Pre-Submission Question Development
Developing clear, focused questions for the FDA covering specific regulatory, technical, testing or clinical issues that could affect your future submission strategy.
Supporting Documentation
Preparing and reviewing the device background, proposed indications, technical information and supporting evidence required to give the FDA appropriate context for your questions.
Testing & Clinical Strategy
Supporting Pre-Sub discussions on proposed performance testing, clinical studies, biocompatibility, software, usability and other device-specific evidence requirements.
Pre-Submission Package
Compiling and reviewing your Pre-Submission package to ensure the information is clear, structured and focused on obtaining meaningful and actionable FDA feedback.
FDA Meeting & Feedback Support
Helping you prepare for FDA interaction, evaluate the feedback received and translate the FDA's recommendations into practical next steps for your development programme.
Who Should Consider an FDA Pre-Submission?
- Manufacturers uncertain about the appropriate FDA regulatory pathway
- Companies seeking FDA feedback before starting significant testing or clinical studies
- Developers introducing novel technologies, indications or device features
- Manufacturers wanting FDA input on performance, software, biocompatibility or clinical evidence plans
- Medical device and IVD companies preparing for a future 510(k), De Novo or other FDA premarket submission
FDA Pre-Submission Documentation Requirements
An FDA Pre-Submission (Pre-Sub) allows medical device and IVD manufacturers to engage with the FDA before making a formal premarket submission or committing significant resources to product development and testing.
Through the FDA’s Q-Submission Program, manufacturers can request feedback on specific regulatory and technical questions relating to areas such as regulatory strategy, proposed testing, clinical studies, software, biocompatibility, labelling and other device-specific considerations.
A well-prepared FDA Pre-Submission package typically includes:
| No | Heading | Contents |
|---|---|---|
| 1. | Device & Product Overview | Description of the medical device or IVD, intended use, indications for use, technology, development stage and relevant product characteristics. |
| 2. | Regulatory Background | Proposed FDA classification, product code, regulatory pathway and relevant previous regulatory interactions where applicable. |
| 3. | Pre-Submission Objectives | Clear explanation of the regulatory or development issues for which FDA feedback is being requested. |
| 4. | Questions for the FDA | Focused and clearly structured questions designed to obtain specific, actionable FDA feedback. |
| 5. | Testing & Evidence Strategy | Proposed performance, biocompatibility, software, electrical safety, clinical, analytical or other device-specific testing plans, as applicable. |
| 6. | Supporting Information | Relevant protocols, study plans, technical information, comparisons, literature or other evidence necessary to support the questions being asked. |
| 7. | Proposed Next Steps | Outline of the planned development and regulatory approach to help translate FDA feedback into the future premarket submission strategy. |
Our Process
Assess & Define
We review your device or IVD, proposed U.S. regulatory pathway and development plans to identify the key areas where FDA feedback would provide the greatest value.
Prepare & Submit
We develop your Pre-Submission strategy, formulate focused questions and prepare the supporting information needed to create a clear and structured FDA Pre-Sub package.
Engage & Implement
We support your interaction with the FDA, review the feedback received and help translate it into practical actions for testing, product development and your future U.S. market submission.
Medical Devices we support
We support Technical File preparation for a wide range of medical devices, including:
- General and non-invasive medical devices
- Electrical and electromechanical medical devices
- Software as a Medical Device (SaMD)
- Connected and digital health medical devices
- Reusable medical devices
- Sterile and single-use medical devices
- Diagnostic and monitoring medical devices
- Implantable and surgically invasive devices, where eligible for the 510(k) pathway
Cost of Service
FDA Pre-Submission (Pre-Sub) Services
From
Gain valuable FDA feedback before committing to significant testing, clinical studies or a formal U.S. market submission. Patient Guard will help develop your Pre-Submission strategy, prepare focused questions and supporting documentation, and guide you through the FDA interaction.
Costs
- FDA Pre-Submission Service – from £3,500
- Regulatory Strategy Review – Included
- Pre-Sub Questions & Package Preparation – Included
- FDA Meeting Preparation & Feedback Review – Included
Pricing depends on device complexity, the number and scope of regulatory questions, available supporting documentation and the level of FDA interaction required. Additional technical work, testing, clinical studies and other third-party costs are not included.
Time Lines
Week 1 – Assessment & Pre-Sub Strategy
We review your medical device or IVD, proposed FDA pathway, development plans and key regulatory questions to define the scope and objectives of the Pre-Submission.
Weeks 2–4 – Pre-Submission Preparation
We develop focused questions for the FDA and prepare the supporting technical, testing, clinical and regulatory information required for a clear and structured Pre-Sub package.
FDA Feedback – Meeting & Next Steps
We support your FDA interaction, review the feedback received and translate it into practical actions for your development programme and future U.S. market submission.
Timelines are indicative and depend on device complexity, documentation readiness and the scope of the Pre-Submission. FDA scheduling and response timelines are outside Patient Guard’s control.
Frequently Asked Questions (FAQs)
What is an FDA Pre-Submission?
An FDA Pre-Submission (Pre-Sub) is part of the FDA’s Q-Submission Program and allows medical device and IVD manufacturers to request FDA feedback before making a formal premarket submission. It can help clarify regulatory expectations and inform important development decisions at an early stage.
Is an FDA Pre-Submission mandatory?
No. A Pre-Submission is generally voluntary, but it can be particularly valuable where there is uncertainty around the regulatory pathway, testing strategy, clinical evidence, software, biocompatibility or other device-specific requirements.
When should we consider an FDA Pre-Submission?
A Pre-Submission should be considered early enough for FDA feedback to influence your development programme. This may be before undertaking significant performance testing or clinical studies, finalising protocols, or preparing a 510(k), De Novo or other FDA premarket submission.
What questions can we ask the FDA during a Pre-Submission?
Manufacturers can seek FDA feedback on specific regulatory and technical matters, such as regulatory strategy, proposed testing methods, study protocols, clinical evidence, software documentation, biocompatibility and other device-specific issues. Patient Guard helps develop focused questions designed to obtain useful and actionable feedback.
What happens after the FDA Pre-Submission?
Patient Guard helps you review and understand the FDA’s feedback and translate it into practical next steps. This can be used to refine your testing programme, evidence strategy, product development activities and subsequent U.S. regulatory submission.
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