On April 9, 2013, FDA issued a draft guidance document, entitled “Molecular Diagnostic Instruments with Combined Functions,” to explain the agency’s current thinking on the regulation of molecular diagnostic instruments that have both “device” (e.g., in vitro diagnostic (IVD)) and “non-device” (e.g., basic research) functions and of associated software and firmware. The draft guidance could effectively impose new regulatory obligations on in vitro diagnostic (IVD) manufacturers.
The draft guidance is the latest in a series of efforts by FDA to expand its oversight of research and clinical laboratory testing activities. In 2011, the agency issued a widely-criticized draft guidance broadly interpreting its authority over “research use only” and “investigational use only” reagents—which have long been used for a wide variety of laboratory applications. More recently, FDA has been considering its regulatory approach to laboratory tests that incorporate next generation sequencing (NGS) technologies.
The draft guidance would open the door to FDA scrutiny of a broad range of non-device functions during the clearance or approval process and would impose additional post-market obligations on manufacturers with respect to those functions. In particular, premarket submissions would have to include information demonstrating that the “non-device” functions would not interfere with the performance of the “device” functions, on the theory that the “non-device” functions could potentially affect the safety or effectiveness of the instruments when used for clinical diagnostic purposes. Such submissions would also have to include “risk/hazard analysis” addressing the coexistence of the functions and identifying appropriate mitigation measures, such as menu options that clearly distinguish between “device” and “non-device” functions. Post-market, manufacturers would have to provide separate labeling, including instrument manuals, for the “device” and “non-device” functions. They would also have to report malfunctions, injuries, and deaths associated with non-device functions, and assess whether changes to non-device functions could trigger the obligation to submit a new 510(k), a process that is already confusing and that carries significant FDA enforcement risk.
The draft guidance also makes the anomalous recommendation that manufacturers should not combine claims for approved or cleared functions with those for non-device functions (e.g., statement that a device can be used for “ detecting MRSA and for basic research."). This approach seems inconsistent with FDA’s approach to promotion in the context of other types of dual-function products, such as fluoride-containing toothpaste that is promoted for both cavity prevention and whitening and breath-freshening functions or medical chairs that are promoted for both patient management and comfort.
Neither the draft guidance nor the accompanying Federal Register notice identifies a public health threat or other impetus for the issuance of this draft guidance. In practice, molecular diagnostic instruments often incorporate functions needed by both research and clinical laboratories, and combining multiple functions in a single instrument expands its utility to accommodate a broad range of users who otherwise would need to purchase multiple units or forego desired functionality. Increasing manufacturer burdens associated with adding non-device functions could reduce the options available to laboratory customers and thereby increase expense and decrease efficiency in basic research, test development, and clinical testing activities that depend on these instruments.
The deadline for submitting comments is July 8, 2013. The draft guidance is available here.