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FDA labeling guidance gets mixed reviews
FDA's draft document, Guidance on Labeling for Laboratory Tests, has elicited a variety of reactions from industry, both good and bad, according to Carolyn Jones, director of in vitro diagnostics and biomedical technical programs at the Health Industry Manufacturers Association (HIMA; Washington, DC).
"Some companies think it's awful, while others think there are concepts in it that should be investigated and used," Jones says. The biggest concern at this point, Jones says, is the new terminology used in the document.
The idea behind the guidance is to provide manufacturers with a format for labeling that will characterize the performance of clinical laboratory assays for both laboratories and healthcare providers. To accomplish this, the document proposes two endpoints for assessing the diagnostic performance of new IVDs: operational truth and laboratory equivalence.
It is just this terminology, however, that has HIMA concerned. "In the past, manufacturers compared their new device to a predicate device and provided sensitivity and specificity information on the labeling. Now FDA wants manufacturers to include the new categories of operational truth and laboratory equivalence, which is information that users are not used to," Jones says.
HIMA is also concerned that the absence of sensitivity and specificity information on labels will be a difficult change for the laboratory community to adjust to.
According to Steven Gutman, director of the division of clinical laboratory devices at FDA's Center for Devices and Radiological Health (CDRH), the document was prompted by difficulties with discrepancy resolution when labeling new devices. "New statistical concepts about discrepancy resolution have made us reassess the descriptive techniques we're using. How do you deal with new concepts when looking at old tests?" The agency's hope is that the new information will enable users to resolve the problems caused by statistical biases in current methods, he notes.
The four major points covered by the labeling guidance are as follows:
- For situations in which a candidate device is being compared to a "true" diagnostic state, the case definition against which new test results are being compared should be clearly stated and both strengths and limitations likely to result from the selection of this definition should be discussed.
- For cases in which a candidate device is being compared to a predicate, the predicate assay and conditions under which it is performed should be defined.
- The case definition of positive and negative results being used to characterize a new test should be independent of results derived from testing with the new device and should be uniformly applied to all samples.
- Discrepancy analysis may be performed and described in the submission and package insert if statistically valid techniques are employed.
Both Jones and Gutman emphasize that the guidance is merely a straw-man document. The agency intends to use it as the basis for collecting feedback from both industry and professional groups. —Sally Lane
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