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Medical Devices

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Appendix 1: Regulatory Decision Tree (21 CFR Part 812) for IVD Investigational Studies

If the device is a Pre-amendments device (other than transitional) used according to the labeling in effect at the time, or if it is a device, determined by FDA as substantially equivalent (SE) to a pre-amendments device, used according to the labeling reviewed as part of the SE determination, then the study is exempt from 21 CFR Part 812, except for 812.119. The study is also exempt, from 21 CFR Part 812, except for 812.119 if the above is not the case, but all of the following are true concerning the device: (1) It is not invasive, (2) The study does NOT involve invasive sampling, (3) It will not be used as a diagnostic procedure without confirmation by a medically established product or procedure, and (4) The sponsor complies with the applicable requirements of 21 CFR 809.10(c). If any of the above are not true, and the device is significant risk, apply to FDA for an IDE. If the device is invasive and is not significant risk, follow 812.2(b) – abbreviated IDE requirements. If the study involves invasive sampling, and the device is not significant risk, the next question to ask is whether the device will be used as a diagnostic procedure without confirmation by a medically established product or procedure. If the answer is no, and if the sponsor complies with applicable requirements of 21 CFR 809.10(c), the device is exempt, from 21 CFR Part 812, except for 812.119. If the answer is yes, apply to FDA for an IDE if the device is significant risk. If the device is not significant risk, follow 812.2(b) – abbreviated IDE requirements.

    
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