What regulation applies to research use only (RUO) or investigational use only (IUO) In Vitro Diagnostic (IVD) products?

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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 FD&C Act if those devices comply with the procedures and conditions prescribed by that section and by that regulation.

For example, devices intended for investigational use that meet applicable requirements may be exempted from premarket notification and premarket approval requirements of sections 510, 515, 520(g)(2)(A) of the Act (21 U.S.C. 360, 360e, 21 U.S.C. 360j(g)(2)(A)); see also 21 CFR 812.1(a).

A product’s intended use refers to the “objective intent” of those responsible for labeling the product. Intent is determined by the expressions or by the circumstances surrounding the distribution of the article.

About the Author
Proxima CRO Team
Joel Reid
Regulatory Affairs Associate

Joel has a Bachelors Degree in Psychology and German. He also has undergraduate research experience in neuroimaging at the Waco VA.

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