Medical Device Submissions Medical Device FDA Pre-Submission (Q-Sub) Support

Set your device up for regulatory success with strategic Q-submissions that clarify FDA expectations, validate your approach, and eliminate costly surprises before you invest in formal submissions.

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Get FDA alignment early and maximize the opportunity for submission success

The Q-submission (formerly Pre-Submission) program offers invaluable opportunities to obtain FDA feedback on planned studies, regulatory strategies, and submission approaches. This free, non-binding interaction can save months of development time and millions in misdirected efforts. Yet many sponsors underutilize this resource or approach it without clear strategies.

Effective Q-submissions require more than listing questions. You need:

  • Strategic framing that guides FDA toward actionable feedback

  • Supporting materials that show preparation and seriousness

  • Well-structured questions that elicit specific guidance rather than generic responses

The goal isn’t just answers—it’s alignment that de-risks your regulatory pathway.

Our pre-submission specialists know how to maximize these FDA interactions. We craft focused packages that secure meaningful feedback, prepare presentations that build confidence, and help interpret FDA responses to guide your program forward.

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Our pre-submission services include:

  • Q-submission strategy and timing optimization
  • Question development and prioritization
  • Supporting documentation preparation
  • Predicate comparison strategies
  • Clinical study protocol feedback requests
  • Statistical analysis plan review
  • Submission pathway confirmation
  • Classification and product code verification
  • Meeting preparation and FDA presentation support
  • Response interpretation and action planning
  • Documentation for future submissions

FDA Q-submission types we support:

  • Traditional Q-submissions (written feedback)
  • Q-submission with meeting requests
  • Informational meetings
  • Breakthrough device designation requests
  • Safer Technologies Program (STeP) requests
  • Clinical protocol agreements
  • Accessory classification requests

Click to expand How we make Q-Submissions work

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We organize every Q-submission around specific workstreams so you get targeted FDA feedback, not generic responses.

  • Strategy & Questions

    • Regulatory pathway & classification: product code confirmation, De Novo vs. 510(k)/PMA logic, combination product pathways, accessory determinations

    • Substantial equivalence / De Novo rationale: predicate selection, technological differences, bridging strategy

    • Clinical & performance evidence: need for studies, endpoint selection, control/arm choice, safety monitoring, real-world data

    • Bench & analytical plans: biocompatibility, sterilization, stability, EMC/electrical safety, software validation scope

    • Human factors & usability: study triggers, critical tasks, summative study design, residual risk rationale

    • Software/SaMD & cybersecurity: IEC 62304 class, algorithm change control, SBOM, vulnerability management

    • IVD specifics: performance study design, specimen handling, controls, method comparisons

    • Labeling & indications: claims language, special controls, patient labeling, home-use considerations

  • Evidence & Materials

    • Briefing package: device description, risk summary, prior testing, specific feedback requests

    • Study synopses & protocols: clinical, performance, or bench outlines with endpoints and acceptance criteria

    • Comparative analyses: predicate/competitive matrices, hazard analyses, usability risk tables, software/data flow maps

    • Readiness exhibits: draft labeling, IFUs, cleaning/sterilization flow, biocompatibility gap tables, cybersecurity plans

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The FDA Group Q-submission advantage

  • Strategic focus: Ask questions that matter
  • FDA perspective: Know what feedback is achievable
  • Preparation excellence: Demonstrate readiness for success
  • Interpretation expertise: Understand what FDA really means
  • Program integration: Use feedback to accelerate development

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Why work with The FDA Group?

 
  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

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Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Resource Selection Process

  • In-House Subject Matter Experts
  • Recruiting Team External Search
  • Resource Identification

Resource Presentation

  • CV And Rate
  • Perfect Match Summary
  • Interview Call Coordination

Agreement Processing

  • MSA And Addendums
  • Supplier Qualification
  • Kickoff Coordination

Account Management

  • Project Management Of Resource
  • Satisfaction Management of Client
  • Total Quality Guarantee

Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of remediation requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.

Please contact us to learn more about fulfilling specific FDA pre-sub needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.