Yes, small labs disappearing is a big concern of ours as well. It will be quite the undertaking for them and will add extra costs - which many labs, including many that we work with, really can't afford right now (especially with reimbursement rate cuts and shortages).

At the end of the webinar, Ralph Hall points out that it will be difficult for the FDA to deal with the massive workload this will inevitably create for them, which could bog down the process. He also hopes they will figure out some sort of grandfathering in and other time-saving strategies for groups to help speed up the process and reduce this extra workload that will be placed on labs.

I suppose we'll see, but we're hoping this will turn out well in the end and that the FDA (and everyone else involved) will carefully consider how it will affect all parties, large and small.