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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 Peña, director of the division of neurological and physical medicine...

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