FDA PreCert Program for Software (Companies) - 2017

[yodon]

This looks interesting:


(broken link removed)

https://s3.amazonaws.com/public-inspection.federalregister.gov/2017-15891.pdf (this is currently in the 'unpublished' state - expected to be officially published tomorrow.)


Curious if anyone might volunteer for the pilot?

 

[cwilburn]

I'm putting together a statement of interest. However, we typically do software as part of a medical device, not SaMD as they indicated in the webinar would be their starting point. Hoping they will at least consider us. There were 900+ people on the webinar, and they are only selecting 9, so chances are slim. My company focusing on developing software for medical devices and we have so much experience with many many devices, and I personally love research kinds of things like this.