To Pitch Pre-Cert to Congress, FDA Builds a Case First

To Pitch Pre-Cert to Congress, FDA Builds a Case First

MedTechDive reported that the U.S. Food and Drug Administration is not yet ready to go to Congress to seek new powers for its evolving precertification pilot for software, but it will need new authorities to determine how the experimental path fits into the current regulatory scheme. The article included commentary from Senior Director of ML Strategies Aaron Josephson and Mintz Associate Benjamin Zegarelli.

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MedTechDive

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  • MedTechDive

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  • Benjamin M. Zegarelli

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  • Consumer Product Safety
  • FDA Regulatory

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  • Life Sciences
  • Digital Health
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