FDA Releases Official Draft Guidance for LDTs; 120 Day Comment Period

On September 30, 2014, the FDA officially released its two major guidance documents on LDT regulation: The first guidance covers a framework for FDA review, for risk classification and for proposed LDT safe harbors such as unmet needs.   The second guidance covers "reporting" for LDTs as medical devices, i.e. adverse event reporting.

The guidances were released to Congress on July 30, 2014, under a legislative requirement that Congress be given 60 days notice before the "official" release and comment period.  Which starts now.

The documents are dated October 3, 2014, so the 120 day comment period will extend until about January 1, 2015.

FDA Draft Guidance for the LDT Regulatory Framework, here.
FDA Draft Guidacne for LDT Adverse Event Reporting, here.

Federal Register notice of the release and comment period - for Framework, here; for Reporting, here.

The FDA commented it made no changes to July documents, except in the definition of combination diagnostic and in the exact grammar for "traditional LDTs" composed of components legally marketed for clinical LDT use (e.g. ASRs).  They clarify that they are proposing special allowances when LDTs are made from components marketed legally ^for clinical test use.  RUOs are marketed legally, but not marketed legally ^for clinical test use.