• Provision Consulting Group

FDA, guidance of Pre-Submission




We want to give you some advice on Pre-Submission which leads to successful FDA approval.


FDA offers a Pre-submission program and provides feedback options for a pre-submission meeting request to determine which option is best for your company's circumstances.


The purpose of a pre-submission meeting is to ask and obtain answers to your questions directly from the FDA.



The Pre-Sub should indicate your preferred method of feedback and the date of your scheduled meeting with FDA.


FDA offered three options for methods of feedback :


  • a face-to-face meeting

  • a conference call

  • an email response



A Face-to-Face Meeting


There are threel things your company should consider for a face-to-face meeting.


1. Understanding the FDA is very important.


FDA is a bureaucracy with an over workload, and government agencies have security concerns. We note that more work and more time will be spent.


Also, You need a compelling reason to justify the extra work and time in a face-to-face meeting with the FDA.


2. One more thing to keep in mind is that a face-to-face meeting with the FDA needs your company's time and money.


3. The most important requirement to consider is that a pre-submission meeting is limited to one hour.


This hour is a question-and-answer session, and you only have a few minutes to introduce your company, team and your products.



Therefore, the best way to have a face-to-face meeting is :


  • prepare thoroughly

  • conduct an efficient meeting

  • ask smart questions



However, there are times when you have to visit the FDA in person if you have a strong demonstration and the video isn't enough.

There is one time when you should visit the FDA face-to-face–if you have a powerful demonstration and video just isn’t good enough.




Conference Call



1. Conference calls' biggest advantage is that it saves you time and money.


Conference calls and emails with the FDA don't require travel.


2. Conference calls are allowing you to mute the call.


While muted, you can have a discussion or make a comment with your team.


3. It is possible to provide information and videos of simulated use for your device before the meeting.


However, the FDA will likely want a conference call with FDA to ask clear questions when discussing a performance test plan or clinical study protocol.




Email



1. Specifying an email response will usually get your questions answered faster and the procedure is very simple.


2. You can have detailed feedback from the FDA agency.


In face-to-face meetings, conference calls, and email responses meetings, agencies from the FDA can provide their feedback for an hour.


During this hour, you speak only a fraction in conference calls and the FDA agency may provide less feedback in a face-to-face meeting and conference calls.




For all the feedback methods you choose, you can always follow up and have additional feedback from the FDA after receiving an initial response to Pre-Submission.


* Note: To learn more about the request 'Pre-Sub' meeting with the FDA, we recommend you to watch and listen to a webinar on the topic.




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their time and money most efficiently.


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If you have questions about FDA regulation of medical devices

or importing of medical devices to the United States,

please CONTACT US.


Office 1-909-493-3276

Email ask@provisionfda.com