The IDE Checklist should be used to determine if an IDE is needed.
The IVD Regulatory Assessment Guide should be used to help determine when an In Vitro Diagnostic Device is subject to 21 CFR 812, the FDA's IDE regulations.
The IDE Checklist should be used to determine if an IDE is needed.
The IVD Regulatory Assessment Guide should be used to help determine when an In Vitro Diagnostic Device is subject to 21 CFR 812, the FDA's IDE regulations.