OIVD s Steve Gutman Says FDA Plans to Consider Changing ASR Regulations | GenomeWeb

The FDA is considering changes in its regulations for analyte specific reagents, Steve Gutman, the director of the agency’s Office of In Vitro Diagnostic Device Evaluation and Safety, part of the Center for Devices and Radiological Health, this week.

The FDA’s ASR regulations were written in 1997 and enacted in November 1998 (read the original document here).

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