Zdrowie i gospodarka · 9.04.2013
Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Molecular Diagnostic Instruments with Combined Functions." This draft guidance document provides industry and Agency staff with FDA's current thinking on regulation of molecular diagnostic instruments that have both device functions and non-device functions, and on the type of information that FDA recommends that applicants include in a submission for a molecular diagnostic instrument that measures or characterizes nucleic acid analytes and has combined functions. This draft guidance is not final nor is it in effect at this time.