pziemlewicz
Involved In Discussions
Last December, I had what I thought was a pretty solid Human Factors Validation Plan for Class 2 device seeking 510(k). Enter COVID-19: Interactions with clinicians have been forced virtual and said plan went out the window. Has anyone attempted a virtual summative study?
I'd hoped to see some guidance from the FDA, but no such luck. Once a plan is in place, it can be reviewed via Q-sub, but I'm struggling with how to start writing it. Shipping devices directly to participants just seems way too risky/uncontrolled.
I'd appreciate any feedback from others navigating the same. Thanks in advance.
I'd hoped to see some guidance from the FDA, but no such luck. Once a plan is in place, it can be reviewed via Q-sub, but I'm struggling with how to start writing it. Shipping devices directly to participants just seems way too risky/uncontrolled.
I'd appreciate any feedback from others navigating the same. Thanks in advance.