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FDA Issues Draft Guidance on Molecular Dx Instruments with Combined Functions

NEW YORK (GenomeWeb News) – The US Food and Drug Administration is looking for feedback from the medical devices industry as it reviews its policies for handling how molecular diagnostic devices that have combination functioning, such as real-time thermocyclers, are used to perform multiple assays and may be best regulated.

In a new draft guidance it has released for comments, the FDA has provided recommendations on how these combined-function molecular diagnostic instruments should be regulated. The document also covers the type of information that should be provided in a premarket submission for a molecular diagnostic instrument that measures human or microbial nucleic acid analytes and which also has combined functions.

These types of instruments are not generally approved or cleared alone, the FDA said, but with accompanying assays, because their safety and effectiveness cannot be evaluated outside of the context of the assays.

Among the recommendations in the draft guidance is that software which accompanies molecular diagnostic instruments that do not require approval or clearance should be designed so that it clearly separates the functions that have been approved from those that have not or those that do not require approval at all.

As an example, a manufacturer would include controls that would not allow users to switch the use of an instrument without going back to a startup screen. "This approach may serve, for example, to effectively separate the software functions and prevent any confusion on the part of the user as to which function the instrument is performing and to provide a protective mechanism that prevents the user from altering any approved/cleared function parameters," the FDA said in the draft guidance.

The agency also wants manufacturers who already have instruments approved or cleared that perform functions that do not require approval to address its recommendations in any new premarket assay submissions related to the approved device.

The FDA said it will consider setting several conditions for determining whether to grant approval or clearance for an assay with combined use and functions. Device makers may be expected to show that functions that do require approval are not affected by other functions that do not require approval. For example, a sponsor may show that the use of functions that do not require approval will not interfere with those that do, such as the use of an analyte test panel before a function is performed, recalibration procedures, or instrument cleaning and maintenance.

Sponsors may provide a risk/hazard analysis that covers functions that require and do not require approval and clearance, and they should consider using designs that help to demarcate different functions, such as clear menu options and grayed-out software options for functions that are not available. Device sponsors also should separate labeling for approved and cleared functions from those that are not, and they may not misbrand devices by promoting non-approved assays and reagents as if they are approved for a specific use, or imply that FDA has approved functions for which approval isn't required.

The FDA document also covers some issues related to how combination use devices should be promoted or labeled.

Under its new proposals, sponsors may promote their instruments as approved or cleared for use with assays that are cleared for use on that instrument, and promote them for uses that do not require approval, so long as they are not implying or claiming that the instruments have been approved. But sponsors under the planned rules should not combine the approved or cleared claims with others, saying, for example, that "you can use this instrument for detecting MRSA and for basic research," the FDA said.

The FDA also said it will review assays submitted by third-party developers that are designed to be run on user-configurable molecular diagnostics instruments on a case-by-case basis "to determine whether risks are adequately mitigated." The agency expects that at a minimum these developers should provide end users with complete instructions on how to use these assays on the cleared instruments.

The guidance also covers hardware and software changes and modifications to existing devices that would require premarket approval or submission for a 510(k) application.

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