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Combo-Product Sponsors Could More Easily Get Device Designation At US FDA

 
• By Michael Cipriano

Commissioner Gottlieb says upcoming guidance could help nudge products into preferred device realm if they are on cusp between drug or device jurisdictional designation.

Touch the future,Interface technology, the future of user experience.

Combination product sponsors with therapies on the fence between a drug or device jurisdictional designation may have an easier time getting their product into the less stringent device space as the US FDA will soon be putting out guidance on making that process more efficient.

Testifying before the House Energy and Commerce Health Subcommittee July 25, Commissioner Scott Gottlieb explained that the guidance will "make some further process reforms that I think is going to make it more efficient for products that sit on that cusp to move into the device

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