Why do we need FDA pre-submissions?

It takes 75 days to schedule a pre-submission meeting with the FDA. Is it worth the wait?

1. Do you know how many samples you need to test?
2. Do you know which size is the worst-case scenario?
3. Can we conduct human factors testing at a conference in Europe?
4. Is clinical data needed?
5. What information will the FDA want for a CLIA waiver?
6. Which biocompatibility test do we need to perform?
7. Is the rationale for no data logging for cybersecurity acceptable?

These are just a few examples of questions we ask in FDA pre-submission meetings?

Join us on Friday, October 25, to learn why you need an FDA pre-submission meeting.

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