FDA officials share guidance on de novo device classifications and upcoming MDUFA VI changes at MedTech Conference

At the MedTech Conference in Boston, FDA officials and industry experts discussed de novo classification requests.

They offered practical tips for companies seeking de novo designation, stressing the need for clear evidence and early agency interaction.

The session also reviewed proposed changes under the Medical Device User Fee Amendments (MDUFA VI), noting how new fee structures and review timelines could impact future device submissions.