When conducting any FDA meeting, 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. In order to accomplish these goals, punctilious planning and organization is essential and leaving the FDA with a positive impression of you and your device is critical. Conducting a flawless meeting requires the expertise of a professional. The Weinberg 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
The Weinberg Group’s medical device-related FDA meeting services include:
A Pre-Submission is a formal written request seeking FDA’s feedback before an application is submitted for review. Sponsors can request FDA’s feedback in writing or in a formal meeting or teleconference with the Agency. Pre-Submissions are not required, but if applicants seeking additional feedback from the FDA can submit a Pre-Submission prior to the filing of the following medical device applications:
- De Novo Request
- CLIA Amendments
Despite the fact that they are not required, Pre-Submission meetings are extremely beneficial and strongly recommended by the FDA and The Weinberg Group alike. Pre-Submission meetings afford sponsors the opportunity to obtain feedback from the Agency prior to the submission of an IDE or marketing application.
Benefits of Pre-Submission Meetings include:
- Allows you to obtain feedback from FDA on your plan so that you don’t waste a lot of time and money by going down the wrong path
- Reduces 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 an opportunity to communicate face-to-face with those reviewing their file. 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, rather than just reading their feedback in a letter or over the phone
- Early interaction with the FDA regarding planned nonclinical and clinical studies can improve the quality of subsequent submissions
- Help sponsors determine an efficient path from deice 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 as well as responses to potential questions or concerns from the FDA. Achieving the goals and objectives of the meeting is possible, but there are certain actions that must be completed in advance to make sure this happens. The Weinberg 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 have prepared for and attended hundreds of meetings with the FDA giving us insight into the best way to conduct meetings with the Agency in order to achieve our clients’ objectives.
Find out more about FDA Submissions.
Submission Issue Meetings provide applicants with the opportunity to discuss deficiencies that were identified by the FDA during premarket review of a 510(k), De Novo request, IDE, PMA, IND, or 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 staff 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, 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 new device(s) with significant differences in technology 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 aspect of the meeting. 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, The Weinberg 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.
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 FDA 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 The Weinberg Group. Our experience coupled with our knowledge of the medical device and regulatory landscape make us uniquely qualified to assist you through the process of preparing for and conducting a successful PMA Day 100 Meeting.