According to an article on G2 Intelligence, an FDA official believes that the final guidance on lab-developed tests—developed by the FDA—will be delayed until after the fall elections.

The article states, “Scott Gottlieb, MD, resident fellow at the American Enterprise Institute and deputy commissioner of the FDA from 2005 to 2007, said that while in vitro diagnostic test manufacturers are pushing FDA to get the guidance out, there is not a great deal of urgency because ‘there’s not a lot of data that there have been problems in this space.’ ”

Read the original article here.

Source: G2 Intelligence