Should I review the “International Conference on Harmonization; Good Clinical Practice: Consolidated Guideline” (“”ICHGCP””) published in the Federal Register Vol. 62, No. 90, May 9, 1997, pp. 25691-25709 or the draft ISO 14155, “Clinical Investigation of Medical Devices for Human Subjects,” when developing studies for devices that fall within the exemption at 21 CFR 812.2(c)?

Although the ICH document was written for studies of pharmaceuticals, sections of the guidance address study issues common to all investigational products. Thus, these sections of the ICH GCP provide a useful reference regarding the proper conduct of studies.
The draft ISO document specifically states that it does not apply to IVD devices. The draft ISO document is an international document intended to reflect basic practices appropriate to clinical trials worldwide. It does not include all of FDA’s specific requirements for clinical studies and is not presently a standard that FDA has officially recognized; therefore, we do not recommend that you rely on it.