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US FDA Adds 14 New Regulatory Tools To Help It Review Medical Devices

The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.

Different construction tools with hand tools for home renovation on wooden board maintenance and repairing concept.

The US Food and Drug Administration has updated its catalog of recognized regulatory science tools to review medical devices. The list includes the types of tools regulatory reviewers may use to determine if a sponsor’s product meets requirements to get to market.

The FDA added 14 new tools to its catalog on 19 November, which are meant to help review devices,...

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