Last updated:
From usability studies to significant-risk IDE trials, Elemental IRB delivers fast, FDA-compliant review with documented SR/NSR determinations and transparent pricing from $1,500.
Any clinical investigation of a medical device that enrolls human participants needs IRB approval under FDA 21 CFR 56, including IDE studies, pilot and feasibility studies, human-factors validation, and clinical data for 510(k), De Novo, and PMA submissions.
IDE clinical trials, 510(k) and De Novo clinical data, usability and human-factors studies, and software/digital health (SaMD) studies collecting participant data.
Minimal-risk and NSR studies often qualify for expedited review at $1,500 in 3-5 business days, while significant-risk trials receive full board review at $4,000 in 5-10 business days. Elemental IRB documents SR/NSR determinations under 21 CFR 812 and can serve as the single IRB for multi-site device trials.
Yes. Clinical investigations of medical devices that involve human participants require IRB review under FDA regulation 21 CFR 56. This applies to Investigational Device Exemption (IDE) studies, usability and human-factors studies, and clinical data collection for 510(k) or De Novo submissions.
A significant risk (SR) device study presents a potential for serious risk to participants and generally requires both FDA IDE approval and IRB approval. A non-significant risk (NSR) device study requires IRB approval, with the IRB making the SR/NSR determination, but does not require a separate FDA IDE submission. Elemental IRB makes documented SR/NSR determinations as part of review.
Non-significant risk and minimal-risk device studies often qualify for expedited review at $1,500 (3-5 business days). Significant-risk device trials typically require full board review at $4,000 (5-10 business days). Pricing is published upfront, with minor amendments and continuing review included.
Yes. Usability, human-factors, and validation studies that enroll human participants require IRB oversight. Many are minimal-risk and qualify for expedited review, helping device teams generate the human-factors evidence FDA expects without lengthy delays.
Expedited reviews are completed in 3-5 business days and full board reviews in 5-10 business days from the point your submission is confirmed complete. Rolling review means there is no wait for a scheduled board meeting cycle.
Yes. As part of reviewing a device investigation, Elemental IRB documents whether the study is significant risk or non-significant risk under 21 CFR 812, which determines whether an FDA IDE is also required before the study can begin.