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→Study Design
IDEs can be foregone if any of the exemption criteria at 21 CFR 812.2(c) (Investigational Device Exemptions 2014) are met. [...] A diagnostic device, if the sponsor complies with applicable requirements in 21 CFR 809.10(c) and if the testing: is non-invasive, does not introduce energy into the patients body, has the diagnosis confirmed by a medically accepted alternate method.
=Study Design=
=Study Design=
==Inclusion Criteria==
==Inclusion Criteria==