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REP. BARTON CRAFTING AMENDMENT TO PROVIDE PMA ALTERNATIVE FOR NOVEL, LOW-RISK PRODUCTS THAT LACK PREDICATES; SENSORPAD APPROVAL BILLS ALSO INTRODUCED

This article was originally published in The Gray Sheet

Executive Summary

House Commerce/Oversight Subcommittee Chairman Joe Barton (R-Tex.) is drafting an amendment to device law that would allow lower-risk devices for which no pre-1976 predicate device exists to be cleared through the 510(k) process rather than requiring premarket approval applications.
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