Devices

Device Breakthrough Designation May be Made Public: Shuren

CDRH director Jeffrey Shuren has told The MedTech Conference in Boston that FDA may be willing to make public which devices are awarded breakthrough designation. He also said he predicts that the number of breakthrough devices getting final marketing approval will spike in about a year.

MedTechDive reports online that historically FDA has not made the designations public but, according to Shuren, “it would be worthwhile to hear more from companies as to the comfort level on doing that. We have tried to be respectful that we do, in fact, have a number of companies who do not want it to be public yet, just from a competitive standpoint. And so we have not put out a list or anything that’s in the public domain if it hasn’t been said by the companies.”

Shuren said that so far 12 devices have received a breakthrough designation.

Device Breakthrough Designation May be Made Public: Shuren

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