Pre-submission meetings are a good opportunity to interact with regulators, educate them on your technology and gather valuable feedback for your submission.
However, if not properly planned or executed, the results of the meeting may frustrate sponsors and end up being and a waste of time for all involved.
To maximize outcomes for regulator interactions during pre-submission meetings I have outlined some strategies below:
- Plan and prepare
Planning and preparing seem like obvious and straightforward activities, however, there are some key things you should focus on during the planning phase.
Pre-submission meeting package
The pre-submission meeting package is a key deliverable that is submitted to the regulator in advance of your meeting. It sets the stage for your meeting and is the regulator’s first glance at a future file they will be reviewing.
The key to this document is to provide an executive summary that tells the story of your device and introduces the overall concepts to the reviewer. Providing a clear and concise objective or goal for your meeting will help align the reader with what you are trying to achieve.
Ensuring your package is well summarized and presented (summary tables, figures, and diagrams, introductory and concluding paragraphs) helps to paint a picture for the reviewer and bring them up to speed on the technology you are trying to bring to the market.
The key is to avoid overloading the regulator with data, protocols, and reports without providing summaries. This approach will likely lead to confusion and an ineffective meeting as the regulators may become ‘lost’ in the data.
The purpose of this meeting is not a submission review, and the regulator will not be looking at all the reports in detail or commenting on anything problematic or missing.
The second objective is to lead an effective and efficient presentation. Be sure to assign roles and responsibilities to the members of the presentation team and conduct rehearsal meetings to ensure you have the flow and timing nailed down.
You should also take the time to prepare for potential questions from the regulators and assign team members to own questions related to their particular areas of expertise. Keep in mind regulators are focused on the risk/benefit profile of your device so plan for, and rehearse how you will address questions related to device’s safety and effectiveness, and tie your response back to these key themes whenever possible.
- Include key stakeholders
Bringing the right people to the table gives credibility to your meeting and can help you address difficult technical questions that may arise during the discussion. You don’t need to bring an army, however, don’t hesitate to bring the subject matter experts you think you’ll need based on the focus of your discussion.
For example, if your focus is clinical strategy, size and methodology of your clinical trial, you may want to invite a key KOL, Principal investigator, or clinician that has experience with your device. You could also include a statistician that can speak to how you derived the sample size of your trial.
If your talk is focused on your biocompatibility strategy, you may consider bringing a toxicologist to the meeting or someone well versed in toxicology. If your device is software based, you may want to bring a software engineer to the conversation or an expert in cybersecurity or software validation.
If you don’t bring the right people, you may not be able to address the questions during the meeting and will have to take them away to address at a later date. This may lead to unnecessary back and forth interactions during the review process and a delayed approval or clearance.
- Craft your questions
The pre-submission meeting is also an opportunity for you to gain valuable insights and information from regulators. One of the key ways to solicit specific feedback is to carefully craft your questions. If you ask vague, open-ended questions you’ll get vague, general answers from the regulators.
However, if you carefully craft your questions with the intention of eliciting specific feedback, you’ll gain valuable information that will help with your submission. Consider the following framework to help you create a well-crafted question:
- State your position or approach.
- Provide a scientifically based justification.
- Ask the regulator if they agree with your approach.
For example, if you want to know if the regulator agrees with your strategy, there are two ways to ask it, but only one will give you the information you’re looking for. I’ve provided an illustrative example below:
Vague Question: Is the regulator in agreement with our clinical strategy?
Asking this question in this manner may lead the regulator to say: “consult with the guidance document on clinical evidence for this type of device” or “we will have to review the data once the submission is received”.
Better Question: We plan on conducting a clinical study of X number of patients with an X month follow up for our device. The device implant is currently approved (approval reference number) and safety and effectiveness are established (Clinical Evaluation Report located in Appendix 1). There is no change to the fit, form, or function of the implant. The only thing changing is the delivery system and how the implant is delivered to the site.
We have conducted bench and animal testing and a summary report is provided in Appendix 2. Biocompatibility testing has been conducted and results are summarized in Appendix 3. We have conducted an updated risk assessment which is provided in Appendix 4. A human factors evaluation was completed and is summarized in Appendix 5. We believe the number of patients in the proposed clinical trial and clinical endpoint will be able to capture any adverse events associated with the procedure.
Based on the above explanation and supportive evidence included, we believe that the clinical trial size and follow up is appropriate.
Does the regulator agree with this strategy?
By positioning your question using this framework, it shows the regulator that you have done your homework, you understand the regulations, and that you are seeking specific input. This type of approach allows for pointed feedback and the opportunity to discuss particular areas they may not agree with, or gaps in your thinking.
You will leave the meeting with a better understanding of their expectations, and in turn save yourself the additional time and costs of reworking documentation or tests, ultimately leading to a smoother review cycle.
- Incorporate reviewer feedback
Now that the meeting is over, what do you do with the feedback and clarity gained? It’s important you have a scribe at the meeting to capture the salient points as meeting minutes are a required post-meeting deliverable. Regrouping with the team is a good idea to capture the key themes and points of concern raised by the regulators.
If a reviewer makes a comment about a certain test or feature of the device, ensure that your submission addresses their concerns and directs them to the measures you’ve taken to mitigate the identified risk including testing, labeling, or other mechanisms.
Following through by incorporating the regulator’s feedback into your submission builds your company’s integrity and reputation. However, failing to follow through and disregarding the regulator’s comments will likely lead to multiple deficiencies and a lengthier review.
It’s important to approach a pre-submission meeting as a mutual education session. This is an opportunity to educate the regulator about your technology and gain valuable insight on their initial areas of concern or comments on your strategy.
You can set a good first impression by providing a clear and concise briefing document and a well rehearsed presentation. During the meeting, be cooperative, seek to understand their feedback, and craft your questions strategically to get specific answers and valuable input.
Remember, you only have an hour so use your time wisely and ensure you’ve carved out enough time to discuss your questions, so you leave with the information you need to prepare a robust submission package.
Image: StarFish Medical
Nicole Ouellet is the Vice President of Regulatory Affairs and Quality Assurance at StarFish Medical. Nicole has over 20 years of Regulatory & Quality experience in the MedTech Industry. She has a proven track record of navigating key global regulatory and quality challenges and providing strategic pathways enabling the acceleration of business and client objectives. Nicole holds a Masters of Science from the University of Guelph.