When conducting any meeting with the Food and Drug Administration (FDA), the goal is to obtain a clear response to the questions included in your meeting request and leave with a clear understanding of the Agency’s expectations. To accomplish these goals, punctilious planning and organization are essential, and leaving the FDA with a positive impression of you and your medical device is critical. Conducting a flawless meeting requires the expertise of a professional. ProPharma Group is the expert you need. We have a vast amount of knowledge and experience to ensure your FDA meeting is planned and executed as impeccably as possible.
Medical Device Meeting Services
ProPharma Group’s medical device-related FDA meeting services include:
A Pre-Submission is a formal written request seeking the FDA’s feedback before an application is submitted for review. Sponsors can request the FDA’s feedback in a formal meeting or teleconference with the Agency. Pre-Submissions are not required, but applicants seeking additional feedback from the FDA can submit a Pre-Submission before the filing of the following medical device applications:
- Investigational Device Exemption (IDE)
- 510(k) (Premarket Notification)
- Premarket Approval (PMA)
- De Novo Request
- Humanitarian Device Exemption (HDE)
- Clinical Laboratory Improvement Amendments (CLIA)
Even though they are not required, Pre-Submission Meetings are extremely beneficial and strongly recommended by the FDA and ProPharma Group alike. Pre-Submission Meetings allow Sponsors to obtain feedback from the Agency before submitting an IDE or marketing application.
Benefits of Pre-Submission Meetings Include:
- Allows you to obtain feedback from the FDA on your plan so that you don’t waste a lot of time and money by going down the wrong path
- Reduces the chance of any surprises coming up after your application is submitted to the FDA
- Gives you an opportunity to discuss disagreements and/or deficiencies in real-time instead of through a lengthy back and forth process
- Gives Sponsors to communicate face-to-face with those reviewing their files. This human interaction element is key. Our experience is that you can learn a lot more about what the FDA is thinking when you’re in the same room with them, rather than over the phone or simply reading their feedback in a letter
- Early interaction with the FDA regarding planned nonclinical and clinical studies can improve the quality of subsequent submissions
- Helps determine an efficient path from device concept to approval
Pre-Submission Meetings should be meticulously planned and rehearsed before you get in front of the FDA. Time is limited, so it is critical to have a list of specific questions and responses to potential questions or concerns from the Agency. Achieving the meeting’s goals and objectives is possible, but certain actions must be completed in advance to make sure this happens. ProPharma Group will guide you through every step of the Pre-Submission process, from the preparation and submission of the meeting request all the way through the meeting itself and any follow-up required after the meeting is over. Our team of experts has prepared for and attended hundreds of meetings with the FDA giving us insight into the best way to conduct meetings with the Agency to achieve our clients’ objectives.
Submission Issue Meeting
Submission Issue Meetings provide applicants with the opportunity to discuss deficiencies identified by the FDA during the premarket review of a 510(k), De Novo request, IDE, PMA, Investigational New Drug (IND), or Biologics License Application (BLA) application, as well as CLIA Waiver by Applications. The goal is to leave the meeting with the feedback and clarification needed to re-submit an application with a greater chance of approval.
The success of a Submission Issue Meeting depends on how well the Sponsor is prepared. These meetings are typically only one hour long, so all discussion points should be strategically prioritized and planned in advance. Our experts have worked extensively with the FDA and know what it takes to achieve successful outcomes when working with the Agency.
Applicants may request meetings with the FDA with the intention of sharing information without the expectation of feedback. As resources allow, the FDA will grant Informational Meetings if requested for one of the following reasons:
- To provide an overview of ongoing device development when there are multiple submissions planned within the next 6-12 months
- To familiarize the review team about the new device(s) with significant technical differences from currently available devices
Informational Meetings are beneficial for the FDA to help familiarize reviewers and plan resources for upcoming submissions. During Informational Meetings, FDA representatives are in listening mode and will not provide feedback on any meeting aspect. If you are looking for feedback and clarification from the Agency, a Pre-Submission meeting should be considered and requested.
Determining the best meeting to request can be challenging, but we can assist you in the process. Based on your goals and objectives, ProPharma Group can help you determine which type of meeting is most appropriate. From there, we will work with you to prepare for and conduct the most effective meeting possible.
PMA Day 100 Meeting
Following the submission of a PMA application, a Sponsor may request a Day 100 Meeting, in which the FDA will discuss the review status of the application. This meeting will take place no more than 100 days after the PMA has been filed. Before the meeting, the FDA will inform the applicant of any deficiencies that have been identified at that point and what information is necessary to correct those deficiencies.
PMA Day 100 Meetings may include:
- A general discussion of identified issues and discussion of remedial actions
- A discussion of an action plan with estimated dates of completion
- A discussion of the FDA’s estimated timetables for review completion
- Identification of the need for panel involvement
- A discussion of possible premarket versus postmarket requirements
It is critical that Sponsors be prepared for any situation that may arise, which starts with contacting ProPharma Group. Our experience, coupled with our knowledge of the medical device and regulatory landscape, makes us uniquely qualified to assist you through the process of preparing for and conducting a successful PMA Day 100 Meeting.