Decision Diagnostics Corp (DECN)

[Raffis]

GENVIRO S. WILL GET “RUO” APPROVAL EXEMPTION: Section 520(g) of the FD&C Act, 21 U.S.C. 360j(g), provides for the exemption of devices intended for investigational use from certain requirements of the Act if such devices comply with the procedures and conditions prescribed by that section and by regulation. For example, devices intended for investigational use that meet applicable requirements may be exempted from premarket notification and premarket approval requirements.