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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.

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