Sens. Johnny Isakson (R-GA) and Michael Bennett (D-CO) have introduced a bill that looks dramatically alter the US Food and Drug Administration’s (FDA) process for inspecting device manufacturers.
Specifically, the bill calls for FDA to implement a more consistent, risk-based inspection process, as well as to improve communications with device makers regarding inspections and findings.
“The current device facility inspection process lacks transparency, predictability and consistency between facilities,” Isakson said. “This bill is designed to improve communication and consistency in the device facility inspections process, which will allow both FDA and device manufacturers to make more efficient use of resources."- See more at: http://www.raps.org/Regulatory-Focus/News/2017/02/21/26926/Senators-Look-to-Overhaul-Medical-Device-Inspections/#sthash.IzUOZNJm.dpuf
