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FDA Looks To Whittle Down Dx Review Load With Pre-Certs, Third-Party Assists

 
• By Sue Darcey

US FDA Commissioner Scott Gottlieb and the agency’s new diagnostics office chief Tim Stenzel want to use a combination of pre-certification, assistance from third-party reviewers and review exemptions to help quickly clear the tsunami of molecular-based diagnostic tests expected to be submitted to FDA for review in the next several years.

Commissioner Gottlieb speaking at RAPS 2017
FDA Commissioner Scott Gottlieb • Source: Ferdous Al-Faruque

Scott Gottlieb envisions a day when only 10% of new diagnostics will have to undergo pre-market review by US FDA to reach market. The FDA commissioner spoke of his vision to an audience of patient groups, IVD kit manufacturers, and laboratory leaders Sept. 13.

Gottlieb joined Timothy Stenzel, who recently moved from industry to head FDA's Office of In Vitro Diagnostics and Radiological Health, at a meeting organized by the Friends of Cancer Research...

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