Over at Linked In, see an excellent overview of how to view potential FDA regulation of LDT's. By Joe Lennerz of molecular pathology at MGH.
The FDA is planning to regulate laboratory developed tests (LDTs) to ensure patient safety and innovation in diagnostic tests. Although the specific details of the proposal are yet to be disclosed, several assumptions can be made about potential mitigation measures. These may include risk-based approaches for high-risk LDTs, registration and listing requirements for transparency, collaboration with stakeholders for feedback, and emphasis on risk communication and quality control standards. The FDA might also consider special considerations for innovative tests and account for orphan disease exceptions. Fast-track approval and regulatory fee structures could be incorporated, aiming to streamline the submission and review processes.
See publications by Lennerz at PubMed - here.