FDA Launches Breakthrough Devices Program with Draft Guidance, Offering ‘More Agile’ Presubmission Process

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FDA Launches Breakthrough Devices Program with Draft Guidance, Offering ‘More Agile’ Presubmission Process

Dennis Tosh

November 6, 2017 at 11:00 AM EST

The FDA Oct. 25 issued draft guidance outlining its new voluntary Breakthrough Devices Program, intended to help speed to market certain medical devices that provide “more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” The program, mandated by the 21st Century Cures Act, enacted in December 2016, supersedes two earli... Read More

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FDA Launches Breakthrough Devices Program with Draft Guidance, Offering ‘More Agile’ Presubmission Process

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