Article analyzes feedback methods offered by the FDA for a pre-submission meeting request and gives you insight to which option is best for your situation.
In 2014 the FDA published a guidance document about pre-submission meeting requests (i.e., pre-sub meetings). The purpose of a pre-submission meeting is to ask and obtain answers to your questions directly from the FDA. The guidance document has great advice on what to ask the FDA and what you should not ask. The best time to be asking the FDA questions is before you begin your verification and validation testing. The FDA can give you valuable feedback on your testing plan to demonstrate safety and efficacy, but if you already started your testing it’s too late. Unfortunately, the guidance document has no advice on which method of feedback to select or why.
Last Section of Your Pre-Submission Meeting Request
The last section of your pre-submission meeting request should indicate what method of feedback you prefer and what your preferred dates are for a potential meeting with the FDA. There are three options offered for methods of feedback:
- a face-to-face meeting
- a conference call
- an email response
Option 1 – A Face-to-Face Meeting
Some executives believe that face-to-face meetings are critical in establishing relationships with people. However, you need to understand the culture of the people your are trying to build a relationship with. The FDA is an overworked bureaucracy, and government agencies have security concerns. When the FDA meets with visitors they must go to a different building and arrange for their guests to pass through security. This is more work and takes more time. To justify the extra work and time, you need a compelling reason why a face-to-face meeting with the FDA is necessary.
Traveling to the FDA will cost your team money and time that conference calls and emails will not. More importantly, you are limited to one hour for a pre-submission meeting. One hour is barely enough time to ask questions and listen to the answers. You only have minutes to introduce your company, your team and the describe the product. There is no time for relationship building. The best way to impress the FDA is to: 1) prepare thoroughly, 2) conduct an efficient meeting, and 3) ask smart questions.
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.
Option 2 – Conference Call
Conference calls save you time and money, but conference calls also save the FDA time and effort. You won’t personally meet people from the agency, but you can communicate information prior to the meeting and you can provide videos of simulated use for your device. Conference calls do have the advantage of allowing you to mute the call for a moment and make a comment among your team members without the agency listening as well. Whenever you are discussing a performance testing plan or a clinical study protocol with the FDA, you will probably want a conference call to enable clarification questions.
Option 3 – Email
Email responses from the FDA are highly underrated in value. When you specify an email response, you generally receive a response to your questions sooner. You also should receive more information, because each person from the agency is able to provide an hour of their time to write detailed feedback. In a conference call, you are speaking for part of the hour and only one person from the FDA can speak at a time. Therefore, you almost always have less feedback during conference calls and face-to-face meetings. The primary downside to email as a feedback method is that it is not interactive.
Regardless of which feedback method you choose, you can always follow-up with supplemental questions and obtain additional feedback from the FDA after you receive the initial response to your pre-submission meeting request. If you are planning a clinical study, you might seek interactive feedback in a conference call during the pre-submission meeting. Then you can follow-up with a clinical study protocol as a supplement to obtain additional feedback from the FDA.
If you are interested in learning more about a pre-submission meeting request to the FDA, consider watching and listening to a webinar on the topic.
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