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.