FDA plans to use ISO 13485 for Medical Devices Regulation

[yodon]

I think they're a bit preoccupied at the moment.

 

[Ed Panek]

The last update here was from 2018.

 

[Ajit Basrur]

No movement - View Rule

 

[bkelly79]

If I know well, and I also read it earlier that the FDA rules were already written based on EN ISO 13485.
It’s just not yet aligned with the 2016 changes.