On Friday, October 31, 2014, FDA posted on its website an audio recording, transcript, and slides from its October 23, 2014 webinar discussing the draft guidance document titled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).” In the webinar, FDA described the history and development of LDTs and explained the basis for the Draft Guidance’s proposed regulatory framework. Comments on the Draft Guidance can be submitted until February 2, 2015.
FDA also emphasized its interest in obtaining broad stakeholder input on the proposed regulatory framework and announced its intent to hold a public meeting sometime in January 2015 to obtain further feedback from interested parties. During the webinar, FDA acknowledged that “publication of the final guidance document [will] take some time,” given the need for FDA to carefully consider and incorporate potentially significant amounts and types of public input, and further advised that, depending on the comments received and the nature of any revisions to the proposed framework, a second draft version of the guidance might be issued for further public consideration prior to finalization of the guidance.
At a high-level, in its Draft Guidance, FDA defines various types of LDTs. FDA proposes to exercise enforcement discretion for certain of these LDTs, and to require manufacturers of all other LDTs to provide notification to FDA and comply with adverse event reporting requirements 6 months after issuance of the final guidance on LDT regulation. Additional regulatory requirements (e.g., premarket approval or clearance, compliance with Quality System Regulation requirements) would be applicable for some LDTs and phased in over time, depending on the risk level presented by the LDT.