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FDA Gives Insight On Changing Approval Landscape

 
• By Elizabeth Orr

Device center officials at the US agency focused on new approval pathways at RAPS Convergence 2020.

Man pulling curtain of darkness to reveal a new better world. Conceptual change, two worlds, hell and paradise.

The safety and performance pathway and de novo clearance process are combining to reform the US Food and Drug Administration’s approach to device approvals, agency officials said on 14 September at RAPS Convergence 2020, hosted by the Regulatory Affairs Professionals Society.

The safety and performance pathway allows some well-understood device types to be cleared for market via compliance with performance criteria, rather than comparisons to a predicate device. The first two...

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