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Common FDA Pre-Submission Pitfalls

Common Pre-Sub Pitfalls and How to Avoid Them

Avoid common FDA Pre-Sub mistakes such as unclear questions, poor timing, incomplete packages, or ignoring feedback. Learn strategies to stay focused, prepared, and maximize the value of FDA’s input.

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Even with the best intentions, sponsors sometimes make mistakes in their Pre-Submission approach that can lead to confusion or delays. Here are some common Pre-Sub pitfalls and strategies to avoid them: 

Pitfall: Overloading the Pre-Submission with too many questions or topics.

Sponsors occasionally try to “ask everything” in one Pre-Sub, covering a multitude of complex issues. The FDA has found it challenging to address more than about 3–4 substantial topics in a single Pre-Sub. Cramming in too much can result in superficial answers or an overwhelmed meeting.

Solution

  • Prioritize and focus your Pre-Submission.
  • Identify the most critical areas where you need FDA’s input (e.g., overall testing strategy, clinical study design, classification).
  • Limit your questions to those areas.
  • Plan separate Pre-Subs or follow-ups for additional unrelated issues.
  • Quality over quantity ensures meaningful, in-depth feedback.
overloading

Pitfall: Submitting an incomplete or disorganized Pre-Sub package

Missing critical elements (like a device description or specific questions) or sending a jumble of data without clear organization will slow down the process. FDA will place the submission on hold if requirements aren’t met, resetting your timeline.

Solution

  • Use a checklist (such as FDA’s acceptance checklist) to assemble your package.
  • Include all key components: cover letter, device description, intended use, questions, etc.
  • Present information in a logical flow and label sections clearly.
  • Double-check all attachments are included before submission.
  • Conduct an internal review to catch omissions.
incomplete

Pitfall: Unclear or unanswerable questions

Vague, overly broad questions or those asking FDA to make your decisions lead to vague or unhelpful feedback. For example, “Do we have all the tests we need?” is not specific enough. FDA will not design your study for you.

Solution

  • Craft clear, specific, and answerable questions.
  • Propose your solution or plan and ask for FDA’s agreement or suggestions.
  • Avoid questions that seek pre-approval or “bless” a full submission.
  • Clear, targeted questions yield actionable answers.
unanswerable

Pitfall: Providing either too little or too much background information

Insufficient context leads to conservative or generic answers. Excessive unrelated data can overwhelm reviewers and distract from key questions.

Solution

  • Include just enough background for FDA to understand your questions.
  • Provide focused documentation tied directly to each question.
  • Exclude unrelated R&D data that may confuse reviewers.
  • Keep additional data ready for discussion if needed.
background-info

Pitfall: Bad timing – either too early or too late in development

Too early requests yield high-level, less actionable feedback. Too late requests risk disagreement after resource expenditure or rushed submissions.

Solution

  • Request Pre-Sub when device design is finalized or nearly finalized.
  • Have draft plans for testing but before full execution.
  • Avoid brainstorming or fully locked-in data stages.
  • Allow time to pivot based on FDA input.
bad-timing

Pitfall: Ignoring or misinterpreting FDA feedback

Not following or addressing FDA advice can cause deficiencies during formal review. Misunderstanding feedback or team changes can lead to this issue. Conversely, treating feedback as a formal “okay” to do the minimum is also risky.

Solution

  • Treat FDA feedback as guidance to integrate, not optional commentary.
  • Document how each FDA recommendation or concern is addressed internally.
  • If choosing an alternative approach, justify it clearly in your submission.
  • Reference the Pre-Sub and resolution of feedback explicitly in your submission.
  • Addressing feedback streamlines FDA review and demonstrates responsiveness.
ignoring

By being mindful of these pitfalls – and proactively avoiding them – you set yourself up for a much more effective Pre-Submission process. Common themes in avoiding all pitfalls are preparation, clarity, and responsiveness. Prepare thoroughly, communicate clearly, and respond to FDA requirements and feedback diligently. The next section will highlight the strategic benefits that come from doing all this right – essentially, why early FDA engagement (via Pre-Subs) can greatly aid your regulatory success. 

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