Who has the FDA Approved Today?
The FDA publishes an official list of Standalone Grandfathered Determinations here. Today's list is comprised of 30 companies and includes 2,371 predicates. Now, many more may be in process, but we cannot see the list of submissions to the FDA. The top 10 companies received approval on 2,159 predicates or 91.1% of the total.
As a industry, you can see the challenge in front of us all. To meet demand the number of FDA predicates must grow substantially!!!
Complete table of FDA Standalone Grandfathered Determinations