The Tricky Business Of Environmental Control
This article was originally published in The Gray Sheet
From our digital archives: Manufacturers must keep a firm grasp on environmental controls to avoid potentially tough regulatory penalties. “Clearly environmental controls are important, and FDA will and can take major regulatory action when environmental controls aren’t being adhered to,” ex-FDA official Kim Trautman said in September 2011. Communication is cited as an important aspect for firms as they attempt to ensure that facilities meet FDA’s environmental control requirements.
You may also be interested in...
On this week’s podcast we talk about outgoing US FDA chief Stephen Hahn and the role he wants to play beyond 20 January, as an ex-commissioner. We also discuss the US enforcement landscape around COVID-19-related products and how it’s still taking shape.
A new guidance document and a promise to hold a public workshop are just two commitments made by the US agency in a 12 January action plan aimed at AI/ML-based software as a medical device.
The US agency announced on 11 January a recall of the Lotus Edge transcatheter aortic valve replacement (TAVR) system – a device that Boston Scientific stopped making and voluntarily recalled two months ago.