FDA Clarifies Definition of IVDMIAs

The FDA has issued a revised draft guidance in response to comments received on an initial draft guidance for in vitro diagnostic multivariate index assays (IVDMIAs). According to the FDA, many comments received on the initial draft guidance showed that industry construed the definition of IVDMIAs in the document to encompass a wider range of tests than the agency had intended.

The initial document has been revised to clarify the definition of an IVDMIA, and to provide examples of tests that the agency does and does not consider to be IVDMIAs. The revised draft guidance, issued last week, also discusses premarket and postmarket requirements for these assays.

Although the initial guidance has been modified so manufacturers can “more easily determine whether their tests are IVDMIAs,” the scope and intent of the definition of an IVDMIA remains the same, the FDA said.

The revised draft guidance, “In Vitro Diagnostic Multivariate Index Assays,” can be seen at www.fda.gov/OHRMS/DOCKETS/98fr/06d-0347-gdl0002.pdf.