FDA Cobbles Together Pilot For Remote Review Of Manufacturer Records
The coming pilot program would give the US FDA remote access to a manufacturer’s records. It’s another approach the agency wants to try as it feels out the best way to virtually evaluate regulatory compliance during the COVID-19 pandemic.
You may also be interested in...
The US FDA is assessing via a pilot program whether the use of video is helpful when investigators perform remote facility inspections. Meanwhile, the agency’s device center is “working on alternative approaches for assessing a firm’s quality management system,” an FDA official says.
The COVID-19 pandemic is nudging the US FDA to launch a voluntary pilot program that will allow agency investigators to conduct facility inspections virtually, King & Spalding’s Steve Niedelman said on 11 November.
ASTM International is proposing a new standard that will provide a cleaning agent formula for removing dried blood from stainless steel medical devices.