By Michael Mezher – 21 February 2017
Sens. Johnny Isakson (R-GA) and Michael Bennett (D-CO) have introduced a bill that looks to 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.”
According to the bill, inconsistencies in how inspections are conducted across FDA’s foreign and domestic offices create challenges for device makers.
“The frequency and nature of inspections of device establishments are not consistently risk-based and a comprehensive, transparent, risk-based approach to inspections would result in greater focus on more significant risks to public health while reducing the burdens on establishments with a strong track record of compliance,” the bill states.