August 24, 2007 - ASM Submits Comments to FDA on Revised In Vitro Diagnostic Multivariate Index Assays Guidance Document

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Docket No. 2006D-0347

To Whom It May Concern:

The American Society for Microbiology (ASM) appreciates the opportunity to comment on “Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays” published in the Federal Register on July 26, 2007 [Volume 72, Number 143, pp 41081 - 41083]. The ASM is the largest educational, professional, and scientific society dedicated to the advancement of the microbiological sciences and their application for the common good. The Society represents approximately 42,000 microbiologists, including scientists and science administrators in government, industry, and academic institutions working in a variety of areas, including biomedical, environmental, and clinical microbiology.

On March 5, the ASM submitted comments on the September 7, 2006 draft of the Food and Drug Administration’s (FDA) Guidance Document on In Vitro Diagnostic Multivariate Index Assays. The Society is pleased that the FDA clarified many of the confusing points regarding the definition of an In Vitro Diagnostic Multivariate Index Assay (IVDMIA) that were in the September 7 draft Guidance Document. The examples provided in the new draft document are particularly helpful in understanding the types of tests that will and will not be included under the revised IVDMIA definition.

The Guidance may need additional clarification and simplification of the compliance process for laboratories which have not yet developed IVDMIAs. The Guidance still appears to be very manufacturer oriented and is difficult to understand from the perspective of a laboratory director trying to develop such a test. Also, the ASM is concerned that the FDA will have adequate resources available, including additional staff with appropriate expertise to complete the IVDMIA review process in a timely manner.

The ASM supports the initiative of the FDA directed towards improving the efficacy and safety of IVDMIAs; the complexity and implications of such testing certainly require oversight. We welcome the attention and care being applied to the development of effective strategies to achieve that goal. Thank you again, for the opportunity to comment.

Sincerely,

Susan E. Sharp, Ph.D., Chair
Committee on Laboratory Practices
Public and Scientific Affairs Board

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