Pre-submission Meeting Key to Neurological Device De Novo Success
A key component of having a successful de novo submission to CDRH for neurological devices is requesting a pre-submission meeting (see guidance), according to a transcript of a 3/22 webinar for developers and sponsors of such devices automatically placed in Class 3 after (XXX DELETE XXX)a “not substantially equivalent” determination has been issued on a submitted a 510(k).
CDRH officials said they strive to have a pre-submission meeting within 75 to 90 days of the acknowledged receipt of the pre-submission. “We'll aim to provide you with written feedback around three days in advance of your scheduled meeting date,” CDRH biomedical engineer Patrick Antkowiak said. “After you receive this written feedback, if you have no further questions you are certainly welcome to cancel the meeting. I'll note that typically we won’t be able to have a meeting earlier than that 75-day time frame due to the workload considerations for our review staff. We urge you to budget your meeting time accordingly for one-hour meetings as we’re generally unable to hold meetings longer than an hour.”
Antkowiak also pointed out that sponsors can “engage with us in a pre-submission while your device is still in early phases of development. We believe that early FDA engagement with a pre-submission represents a chance to identify potential issues and address them appropriately. This can be particularly helpful if you have very novel device technology, or if you'll need substantial testing or clinical data to support your device’s performance claims.”
Antkowiak said that one common issue that sponsors may have with pre-submissions is having them in a correct e-copy format. Such submissions need to comply with the e-copy guidance. “If you don’t comply with this e-copy guidance your submission will not be logged in and will not be reviewed until we receive a valid e-copy,” he said. “Please note that you should not include data such as data from a clinical study that you may have conducted. It is our policy not to review data in a pre-submission. For a de novo pre-submission, we additionally recommend submitting ... a proposed device class, a discussion of the relevant existing device regulations (and why you believe your device wouldn't fall into those), a risk analysis, and proposed special controls that mitigate those risks.”
Another common issue seen with pre-submissions is not including enough information up front, according to Antkowiak. “While we do recommend that you engage us early in your device development process we believe that at a minimum you should have identified your device’s intended use and key design aspects before sending us a pre-submission,” he said. “Please be mindful that a lack of upfront device description information — especially for devices with novel technologies or that we don't have a history with — may hinder the chance to have a meaningful discussion. So if your submission doesn’t provide enough information up front about your device to understand how it works and how you intend it to be used, we’ll end up asking you a lot of questions, which will take time for you to provide complete answers to. This ends up extending the overall length of the pre-submission review... The more you can explain your device technology and your rationale for how you’ve developed — or plan to develop it — the better.”