Last week FDA issued draft guidance for industry and FDA staff entitled "Molecular Diagnostic Instruments with Combined Functions." This document provides FDA's current thinking on regulation of a growing set of molecular diagnostic instruments that are intended for dual purpose use both as a diagnostic device requiring FDA premarket review and for other non-device functions such as basic research that do not require premarket review. Although not explicitly stated in the guidance, it is clearly directed at the elephant in the room: use of these instrument systems to create laboratory developed tests (LDTs).
The intent of the guidance is to signal manufacturers of these dual-purpose products of the need to put controls into place to assure that the functions on these systems that do not require FDA premarket review will not interfere with those that do. FDA indicates that as part of its premarket review of these dual-purpose devices, it will begin to evaluate whether measures are in place to demonstrate this. The measures being suggested are broad in scope and include use of instrument and software design controls, development of validation procedures for use by laboratories, use of a risk mitigation plan, labeling, and/or cautionary construction of result reports.
FDA clearly signals in the guidance a firewall between uses that are and are not subject to FDA review. Reviews on dual-purpose instruments will be focused only on assuring that approved or cleared products have not been compromised by functions not subject to review. The guidance provides advice on both labeling and promotion of the unreviewed instrument functions.
FDA also clearly recognizes that following approval or clearance of a new dual-purpose instrument; changes in software, hardware, or other system features in the unreviewed components can impact the system as a whole. The agency recommends careful documentation of these changes. When they are expected to have potential for affecting the approved or cleared functions, the guidance notes these should be reported to FDA. Not surprisingly FDA also calls for relevant MDR reporting when events are identified in the unreviewed functions that may affect approved or cleared claims.
The document is nothing if not a bit laconic; both concise in language (only 7 pages long) and understated in tone. But as a follow-up to the previous RUO guidance issued in draft form in June 2011, it is anything but an afterthought. It suggests FDA is still in the game to make changes in the world of IVDs and is continuing to take aim at the odd and illogical rules which allow business models (whether an LDT or IVD) to trump risk in product regulation.