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FDA Q-Submission and Pre-Submission Preparation Consulting for Medical Devices and IVDs



When companies don’t properly prepare to submit an investigational device exemption (IDE), 510(k), or PMA application, it often results in one of two undesirable outcomes: The receipt of a refuse-to-accept (RTA) letter or a lengthy additional information (AI) request from FDA.

Nobody wants to bring either document to their boss, because the remedy always involves more time and more money. FDA offers medical device and in vitro diagnostic (IVD) manufacturers the opportunity to head off potentially costly delays by requesting formal feedback prior to submitting your 510(k) or premarket application (PMA), or before beginning a clinical study on which you are seeking feedback. This is achieved through the FDA Q-Submission (Q-Sub) program, of which the Pre-Submission (Pre-Sub) meeting is most common.

A formal pre-submission meeting with FDA is your best opportunity to gain valuable insight well in advance of submission, greatly increasing your odds of shortening your overall marketing approval timeline.

A detailed FDA regulatory strategy gap analysis helps you understand the most critical unknowns that must be addressed

Pre-submission meetings with FDA are generally limited to an hour, so you better make it count! The information you extract from this meeting can save you thousands of dollars and lots of time, but it is vital that you understand your blind spots.

FDA will assemble all the people necessary to address your concerns, but this is not the format to try rushing through 50 questions. Instead, FDA highly recommends that you limit the discussion to 3 or 4 major topics.

To help you prepare, we first perform a detailed regulatory strategy and gap analysis to pinpoint the weaknesses in your upcoming submission. Using the results of the gap analysis and our extensive experience preparing submissions to FDA, we can laser-focus on key questions you should address to reduce the need to complete additional testing and delay market introduction of your device. 

We can customize an FDA gap analysis to examine any (or all) of these areas:

  • Proposed regulatory strategy
  • Planned predicate devices
  • Indications for use/intended use
  • Clinical study design and protocols
  • Proposed labeling
  • Reprocessing, sterilization, and shelf life
  • Existing/planned benchtop or biocompatibility testing
  • Software/firmware and cybersecurity validation
  • Human factors engineering process

Managing the presentation and meeting with FDA for maximum impact

The creation of the Q-Submission and presentation requires skill to elicit the best response during the meeting. Inexperience contributes to asking the wrong questions in the wrong way and can leave you with a long list of unanticipated action items. Our consultants will leverage their prior relationships with the agency and lead the agenda to help guide the discussion and probe where needed.

Following the meeting, our team can also draft and refine the official meeting minutes that will be submitted to FDA for review. This becomes the official record of the FDA input and next steps, and FDA will generally not deviate from recommendations set forth in that document when they review your submission.

We can help you avoid delays and surprise expense in support of your FDA application

Nobody likes uncertainty. By taking a proactive approach to your IDE, 510(k), or PMA application, we can shorten your time to market. Our team is up to date on current FDA expectations and understands what can trigger an AI request from FDA reviewers. Often those triggers are not obvious in published guidance documents or the Quality System Regulation. By performing a detailed gap analysis, we can make sure you are fully prepared for your Q-submission meeting and beyond.

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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