I wrote
last month about my diabetes diagnosis this year and my
difficult choice to wear a proprietary device (called a
CGM) on my arm 24/7
to continuously monitor my glucose levels. Like my friend and colleague,
Karen M. Sandler — who previously made a much higher-stakes choice to
receive a proprietary implanted defibrillator to keep her safe given her
genetic heart condition — I reluctantly chose to attach proprietary
hardware and software to my body.
FDA mandates how recalls happen, pharmaceutical or medical device.
Do they still exist?
De facto or de jure?
Can you please speak American so I can understand it?
They’re asking “technically or actually in practice?”.
Thanks.
They have to have information.