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FDA Extends Comment Period for IVDMIA Draft Guidance to Oct. 17

NEW YORK (GenomeWeb News) — Molecular diagnostics researchers who were unable to submit comments about the US Food and Drug Administration plan to oversee in vitro multivariate diagnostics now have until Oct. 17 to make themselves heard.
The FDA yesterday said it has reopened the comment period for the "Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Multivariate Index Assays." The draft, issued July 26 with a 30-day comment period, is a revised version of an original draft guidance the FDA published in September 2006.
As GenomeWeb Daily News reported last fall, the FDA defined IVDMIAs as tests that use mathematical formulas to interpret gene and protein data to guide medical decision-making. In the guidance, the FDA said such tests, ordinarily overseen by CLIA regulations, must instead be cleared by the agency due to their complexity.
But in February, representatives from the healthcare and pharmacogenomics communities challenged the guidance by claiming the FDA does not have the right to regulate IVDMIAs, and that the agency's draft represents an antiquated view of a field that is constantly advancing.  
At the time, Steve Gutman, director of the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety, responding by saying that the FDA "always expected that the document was not perfect and I guess you have suggested the same."
The FDA said in the Federal Register yesterday that the latest draft "simplified the definition of IVDMIAs and provided a variety of specific examples to assist sponsors in understanding the definition."
Following publication of the July draft, Gutman explained to GenomeWeb Daily News sister publication Pharmacogenomics Reporter that the FDA was "anxious to respond to these comments and has re-issued the draft to see if we have been responsive to concerns about lack of clarity in the definition of IVDMIAs and concerns over chilling of technology.”
Additional information can be found here.

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