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By Clark Rundell
10/09/07
A New Consideration for Some FDA In Vitro Diagnostic Device (IVD) Submissions
Clark
A. Rundell, Ph.D. DABCC FACB
In vitro diagnostic devices (IVDs) are regulated by the FDA and must be premarket-approved
(or “cleared") through 510(k) application for commercial distribution.
Part of the clearance process requires that a manufacturer satisfactorily demonstrate,
via data, that the device will be manufactured under medical good manufacturing
practices (GMPs) such that it will safely and effectively perform in its labeled
and/or intended use.
Guidance documents(1) are periodically issued by the FDA to assist manufacturers
applying for clearance. An opening paragraph in FDA guidance documents for
510(k) submissions states: “The issues identified in this guidance document
represent those that we believe need to be addressed before your device can
be marketed. In developing the guidance, we carefully considered the relevant
statutory criteria for Agency decision-making.” Relating to this, a new
and very important nuance to the FDA’s approach appeared in a 2005 Class
II Special Controls Guidance Document, “CFTR Gene Mutation Detection
Systems.” Manufacturers submitting 510(k) applications under this guidance
were advised, ”You should include failed assays (e.g., inability to correctly
determine genotype within a sample, reporting of an incorrect result, instrument
failure, or reagent failure) in your description of results.” This recommendation
goes beyond the simple “prove that it works” to ask for a demonstration
of test results or system output when the system doesn’t work as intended.
The identification of this as an “issue … to be addressed” recognizes
the likelihood of failures for complex multiplex tests and the need for users
to be aware and able to identify when failure occurs. It is also an overt step
toward more failure mode analysis in clinical laboratory tests and IVDs, which
our statistician friends(2,3) have been promoting for some time. Data relating
to test failures can certainly be useful to the designers and users of the
IVD product in developing procedures for error detection and quality control.
Such information could also be useful to the FDA in considering the potential
for test failures and failure mitigation. Although failure mode analysis is
already required in GMPs, this emphasis relating to FDA submissions seems like
a good move toward better awareness, by IVD developers and users, of potential
test system errors.
References:
1U.S. Food and Drug Administration, Center for Devices and Radiological Health,
Office of In Vitro Diagnostics Device Evaluation and Safety, IVD Guidance Documents,
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/Results.CFM?Doc_Type=1&Doc_IsCur=1&Doc_OFFICE=OIVD&lookandfeel=1&SORT_ORDER=origin,documentdate%20desc (accessed Sept. 10, 2006)
2Krower, J., “An Improved Failure Mode Effects Analysis for Hospitals,” Arch
Pathol Lab
Med. 2004; 128: 663-667.
3Powers DM. Risk Management for IVDs, Parts 1 thru 3: IVD Technology. 2006;
12 (2, 3, and 4). Available at: http://www.devicelink.com/ivdt (accessed Sept.10,
2006)
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