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FDA Emphasizes Pre-Submissions For Neuro Devices

 
• By Elizabeth Orr

Make pre-submissions early and as complete as possible to ensure speedy review and thorough answers for neurological devices, FDA staff says.

A recent FDA webinar for manufacturers of neurological devices that could be cleared for market via the de novo pathway centered on the importance of pre-submission meetings to ensure a smooth regulatory process.

“If you think it's too early to contact us, that is exactly the right time to contact us,” said Carlos...

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