You have sent FDA a Pre-Submission (Pre-Sub; see FDA guidance here) to get answers to specific questions well before your formal submission (e.g., an IDE or 510(k)). For instance, your technology is very new to the medical device world and you want to make sure that FDA agrees with your testing plan. What happens next?
- Initial acceptance review; setting the date. FDA will perform an “acceptance review” within 15 calendar days of receipt to make sure all the required elements of a Pre-Sub have been included in your submission. After that, they will contact you about setting a date and time for the in-person meeting or phone call.
- FDA internal review. The meeting typically occurs about 90 days after receipt of the Pre-Sub, with a commitment to provide you written feedback a few days before the meeting. FDA will create a team to review the matter, discuss your questions, and finalize their comments. You may get a phone call or email along the way, asking for clarification. As the meeting date approaches, it is advisable to reconfirm the date and time as well as FDA’s proposed list of attendees. Make sure that your expertise matches theirs. If they are including an engineer or statistician, make sure you have one too.
- FDA’s written feedback. FDA will answer your questions and provide you with additional comments. Those additional comments are as valuable as the answers to your questions. If the feedback is all positive, you may decide to cancel the meeting, but in our experience there are always more questions to be discussed.
- Before your meeting with FDA. The guidance states that FDA wants your presentation slides at least two business days before the meeting, but since you will have just received FDA’s comments, you will probably spend most of your time sorting out how you want to respond,so don’t feel an obligation to send the slides.
In our experience, the time between receiving FDA’s comments and preparing for the meeting is usually very intense. You have received feedback on your questions. You have likely received extra feedback. Some of it is clear, some of it is not, some of it is adverse, and some of it is supportive. Your meeting will last only 60 minutes. What topics do you cover?
It helps to remember that the Pre-Sub program is a process. You may need to come back later, perhaps via email, to discuss some of the minor points. MED Institute has considerable experience with Pre-Sub meetings. We are happy to help at any stage along the way.
For more information, please visit our website at http://www.medinstitute.com
Next time: The Pre-Submission meeting.