FDA has asserted it authority to regulate Laboratory Developed Tests, LDTs, as medical devices. In 2016, FDA plans to publish guidance documents explaining the process for bringing devices into the regulatory structure. This will end FDA’s policy of enforcement discretion in which it didn’t, for historical reasons, enforce the device regulations.
Currently, there are draft guidance documents that describe the approach FDA intends to take. However, there was a public meeting on this issue as well as a comment period. These could have significant influence on FDA’s enforcement plan.