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Real-World Examples of FDA Meeting Success

Case Studies: Successful FDA Meeting Strategies

See how companies turned FDA meetings into success stories. From Pre-Subs to advisory panels, our case studies highlight proven strategies, lessons learned, and best practices you can apply to strengthen your own FDA interactions.

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← Back to FDA Meeting Prep & Representation

Nothing illustrates the impact of careful FDA meeting planning and follow-up better than real examples. In this section, we present a series of anonymized case studies demonstrating how companies have turned FDA meetings into pivotal successes. These scenarios showcase various types of meetings – from early-stage Q-Sub engagements to high-stakes advisory committees – and highlight the strategies that led to positive results. Each case study provides insights that you can apply to your own FDA interactions.

Case Study 1: Pre-Submission (Q-Sub) Meeting Streamlines 510(k) Clearance

  • Background:
    A small startup developing a novel orthopedic device was preparing its first 510(k). Unsure about some test methods and the appropriate predicate device, they wisely pursued an FDA Pre-Submission meeting 8 months before their planned filing. Initially, their draft questions were broad and unfocused.
  • Strategy Implemented:
    With guidance from a regulatory consultant, they refined the Pre-Sub questions to be very targeted: e.g., “Does FDA agree that wear testing per ASTM ABC is sufficient in lieu of a new clinical study?” and “We propose predicate XYZ – does FDA concur with this choice?” They submitted a robust briefing package with preliminary bench data. During the meeting, the team clearly presented their device and listened closely to FDA’s suggestions.
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  • Outcome:
    FDA provided valuable feedback, endorsing the predicate choice and agreeing that bench testing would suffice for certain performance aspects (no new clinical trial needed). They did, however, request a couple of additional bench tests. The company integrated this advice – performing those tests and strengthening their 510(k) accordingly. When the 510(k) was filed, it sailed through review with minimal questions. The FDA reviewer even noted that the submission was “well-aligned with prior feedback.” Indeed, by using the Pre-Sub to “get FDA feedback in advance of an application,” the company avoided potential deficiencies. Their clearance came in at Day 70 of review – significantly faster than average – which they attribute to having resolved questions upfront.
  • Lesson:
    A tightly scoped Pre-Sub meeting can eliminate uncertainties and prevent costly detours. By asking the right questions and following FDA’s guidance, this startup turned what could have been a long back-and-forth review into an almost routine clearance. This case reinforces how early FDA engagement “can save time and avoid review deficiencies”.
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Case Study 2: Mastering an FDA Advisory Committee Panel

  • Background:
    A mid-sized device company seeking PMA approval for a novel cardiac implant was informed that an advisory committee panel would be convened. The data were promising, but some safety concerns (a particular complication rate) loomed. In a previous panel for a different device, the company had fared poorly – panelists hammered them with questions they weren’t fully prepared for, leading to a negative vote. They were determined not to repeat that experience.
  • Strategy Implemented:
    This time, they overhauled their panel preparation strategy. They engaged multiple regulatory and clinical experts to help. The team conducted extensive mock panel sessions, with external experts playing the role of FDA and panel members, posing the toughest questions imaginable. They developed a clear and focused presentation that directly addressed the known safety concern (presenting a risk-benefit analysis and mitigation strategy). They also leveraged FDA’s pre-panel feedback: through the Day-100 meeting and subsequent interactions, they understood FDA’s key issues and made sure to have solid answers or data for each. A week before the panel, they even adjusted their labeling to add warnings the FDA and panel might want – showing flexibility and responsiveness.
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  • Outcome:
    During the actual advisory committee meeting, the company’s preparation shone. When panel members raised the anticipated safety concern, the company’s clinical expert was ready with a thorough explanation and additional data analyses to contextualize the risk. They also acknowledged the issue candidly and outlined a proposed post-market study to monitor it, which resonated well with the panel. FDA’s own presentation noted that the sponsor had addressed many of their prior questions. One panelist commented that the sponsor’s briefing book was one of the clearest they’d seen – a result of careful organization and anticipating concerns. The panel voted 9-1 that benefits outweighed risks, recommending approval. FDA approved the device a couple of months later.
  • Lesson:
    Comprehensive preparation and a proactive approach to known issues can transform a panel meeting. By treating the panel almost as a marketing exercise – showcasing data while building trust – the company guided the narrative. As a result, they turned a potentially adversarial meeting into a constructive evaluation. This case underscores the advice that each advisory committee is unique and you must tailor your strategy to likely concerns. It also shows the value of humility and cooperation: instead of denying the device’s risks, the sponsor addressed them and worked with FDA/panel on a plan, which gained them credibility.
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Case Study 3: Turning Around a Stalled Submission with a Submission Issue Meeting

  • Background:
    A company’s De Novo classification request for a digital health device had hit a major roadblock. FDA had issued a “deficiency letter” placing the submission on hold – there were multiple issues, especially around software validation and clinical relevance. The company’s initial responses hadn’t fully satisfied FDA, and time was ticking. Morale was low, and the team feared a denial.
  • Strategy Implemented:
    The regulatory lead proposed requesting a Submission Issue Request (SIR) meeting with FDA – essentially a meeting to address the hold issues in a collaborative way. In the SIR meeting (held via teleconference), the company first acknowledged FDA’s concerns, then walked through each major deficiency, presenting a proposed approach to resolve it (e.g., committing to run an additional usability study, providing an updated software hazard analysis, etc.). Crucially, they let FDA speak and clarify what they needed for each point. It became a problem-solving discussion rather than a standoff. The company also brought in an outside software quality expert to speak to the technical fixes, demonstrating they were taking it seriously.
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  • Outcome:
    The tone of communication improved markedly after the meeting. FDA appreciated the structured approach and the company’s willingness to ask for guidance on how to satisfy requirements rather than just pushing back. Following the meeting, the company submitted a comprehensive response (with new data and documentation as agreed). FDA’s subsequent review went smoothly; within a few months, the De Novo was granted. The company later reflected that without the SIR meeting, they might have kept guessing at FDA’s expectations and failed – the meeting allowed them to “quickly resolve or clarify issues” and get everyone on the same page.
  • Lesson:
    When a submission is in trouble, requesting a formal meeting to address issues head-on can rescue it. The key is to approach the meeting cooperatively: listen to FDA’s needs, and show how you will meet them. This case highlights that even after a rocky start, building a bridge via open dialogue can lead to success. It exemplifies why FDA expanded the Q-Sub program to include Submission Issue Requests – to give sponsors a chance to fix problems faster.
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Case Study 4: Building a Long-Term FDA Relationship through Consistent Communication

  • Background:
    A foreign medical device manufacturer was entering the U.S. market with a line of diagnostic devices. They had multiple 510(k)s and PMAs planned over a 5-year span. Initially unfamiliar with FDA’s processes, their first 510(k) meeting (Pre-Sub) was a bit awkward and hinted at gaps in understanding U.S. expectations. Recognizing this, the company decided to invest in a long-term communication plan with FDA, treating the relationship strategically.
  • Strategy Implemented:
    They hired a seasoned U.S.-based regulatory affairs director. This person established himself as FDA’s primary contact (the “face” of the company in the U.S.). He set up introductory meetings with the FDA review division even when not strictly required – for example, a general Q-Sub just to introduce their technology platform and pipeline. Over the years, before each new submission, the company sought FDA feedback early (sometimes informal emails for minor questions, formal Pre-Subs for bigger ones). They kept meticulous records of every FDA interaction and made sure to address any FDA suggestions. Importantly, they never waited until submission time to communicate; they engaged “throughout the device development lifecycle”. If a year was passing with no submissions, the regulatory lead might still touch base with FDA (perhaps at a conference or via CDRH’s Division liaison) to stay on their radar and inquire about any updated guidance that might affect them.
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  • Outcome:
    Over time, this company became well-known to the FDA division – in a good way. FDA reviewers saw that their submissions consistently referenced prior feedback and met expectations. Minor issues were often handled by a quick call or email rather than formal letters, given the established rapport. Internally, the company faced fewer surprises because they were always integrating the latest FDA thinking (e.g., when FDA issued new cybersecurity guidance, they proactively asked if their upcoming submission should include those aspects – it should, and they did). They ended up with several approved PMAs and cleared 510(k)s, often on first pass. In one PMA’s Day-100 meeting, an FDA reviewer commented that the company “clearly did their homework,” having used multiple Pre-Subs to refine the application – a nod to their continuous engagement strategy.
  • Lesson:
    Cultivating a consistent, long-term communication approach with FDA yields trust and efficiency. By treating FDA not as a one-time hurdle but as a continuous stakeholder, this company reaped benefits like faster resolution of issues and perhaps even a bit of goodwill. It aligns with FDA’s emphasis that early and ongoing Q-Sub interactions “improve quality of submissions and reduce review times.”. The case demonstrates that a strategic plan for FDA communications across projects can elevate a company’s regulatory success overall.
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Conclusion

These case studies illustrate that while every FDA interaction is unique, certain strategies are universally effective: be prepared, be proactive, be collaborative, and follow through. From small startups to global manufacturers, those who approach FDA meetings with these principles find that regulatory hurdles become opportunities – for learning, improvement, and ultimately, success. We help our clients apply these same lessons, tailoring them to their situation. Your company’s story could very well be the next FDA meeting success case study – all it takes is the right approach and execution.

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