The FDA vows to detail progress as the pilot goes forward, including a workshop slated for January 2018. And yes, it’ll accept feedback from both industry groups and the public.
If pre-certification goes forward, it could lead to health apps and features reaching the US sooner than they might if they had to go through a product-focused approval process. That’s potentially great for technological progress. With that said, there are concerns: will the standards be high enough that smaller, less scrutinized companies won’t abuse them? And what happens if a pre-certified company bungles an app down the line? The pilot project may well settle these questions, but there’s no guarantee it will avoid significant problems down the road.
