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    1. Update on Software Precertification Pilot Program: FDA seeks public input

      Update on Software Precertification Pilot Program: FDA seeks public input

      Today the FDA made new information about the Software Precertification (Pre-Cert) Pilot Program available and seeks public input on the updated version of its Pre-Cert Program working model. This version of the working model is the FDA’s current, proposed framework and vision. It outlines the Pre-Cert Program’s key components: Excellence Appraisal and Determining Precertification Level, Review Pathway Determination, Streamlined Premarket Review Process, and Monitoring Real-world Performance.

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