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The worst time to submit a pre-submission request is after you already started your verification and validation (V&V) testing. It’s too late because you are already committed to a testing plan. It takes 75-90 days for the FDA to schedule a pre-submission meeting, and your testing will probably take 100-120 days. Therefore, anything you learn during the pre-submission meeting is too late to have an impact on your testing plan.
I typically recommend submitting a pre-submission request before you have a “design freeze,” but I haven’t thought much about the question, “When is too early?”
Typically I am struggling to get everything complete before a 510(k) submission. However, for pre-submission meetings everything does not need to be complete. In fact, you can continue to submit additional updates to documentation after the FDA receives the pre-submission meeting request. As long as the FDA receives the documentation at least 2 weeks before the meeting the FDA will review your information.
To answer the question of when is too early, I pulled up the diagram of the design control process that I use for training courses. The diagram shows a stage-gate development process, but it also indicates when the risk management activities should be scheduled relative to design activities. I started to redraw the diagram so it was larger, and then I added the various milestones of the 510(k) process. Working backwards…
The 510(k) clearance occurs at the very end of the design process and that’s when the DHF is “closed.”
The 510(k) submission occurs at the end of design verification and validation–assuming you have been preparing the submission in parallel with V&V testing.
The 510(k) preparation begins just after V&V testing begins, because it typically takes about 14 weeks to complete the testing and the 510(k) can easily be prepared in parallel with V&V testing if you devote about 4 hours a week to the preparation.
The pre-sub meeting should take place before the approval of the design outputs (i.e., “design freeze”).
The pre-sub meeting request should be submitted 75-90 days before the target date for your meeting with the FDA. On my diagram that date is approximately around the same time that design inputs are reviewed and approved.
After seeing when the approximate time of the pre-sub meeting request submission, I realized that you can’t really submit a pre-sub request until you have identified the critical design inputs. Therefore, once you have performed a preliminary hazard identification and developed a testing plan, you should be able to review and approve you design inputs. This is really the earliest point for asking the FDA questions.
You also have to keep in mind that the FDAs answers might force to change you design inputs.
If you are interested in receiving a copy of the diagram I described above, please send me an email request at firstname.lastname@example.org. If you are already subscribed to my 510k-tips email list, you should already have an email with this diagram included. You might also be interested in my new blog about how to determine if you can submit an abbreviated 510(k) to save 30 days from your next submission: https://fdaecopy.com/abbreviated-510k/.
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Anil Bhalani It has taken me 45 days to schedule a pre-submission meeting. It is never too early to have a pre-sub meeting. It is always late to find out that you could have done something better.
A pre-submission meeting is to ask the FDA questions and obtain clarifications. So you should have enough information in the pre-sub to answer the question. Remember, bad input - bad output. You will get an accurate answer if all relevant information is provided.
You can ask the FDA to a face to face meeting, teleconference, videoconference or simply ask them to respond in writing.
If the pre-sub is prepared correctly with all the relevant information, you can expect a good answer.
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