Studybox Research FDA guidance, explained
The Documents Behind the Study Design.
Each guidance decoded into what it actually changes about operators, sites, comparators, sample size, and timelines.
Explained
FDA guidance, explained
The documents
09 guidances, decoded
- FDA's recommendations for showing that an IVD is simple and carries an insignificant risk of an erroneous result, the two statutory criteria for CLIA waiver.
Final guidance · 2020
CLIA Waiver Application Guidance
- FDA's study-design recommendations for generating a single body of data that supports both 510(k) clearance and CLIA waiver in one combined submission.
Final guidance · 2020
Dual 510(k) and CLIA Waiver Guidance
- FDA's rules for how to analyze and report performance of qualitative diagnostic tests, including when sensitivity and specificity may be claimed and why discrepant resolution is discouraged.
Final guidance · 2007
Statistical Guidance for Diagnostic Tests
- FDA's overview of study-design principles for the definitive clinical investigation that supports a device marketing submission, with a dedicated section on diagnostic devices.
Final guidance · 2013
Pivotal Clinical Study Design Guidance
- FDA's recommendations for the analytical and clinical studies that support premarket submissions for influenza A and B detection and differentiation tests.
Final guidance · 2011
Influenza IVD Performance Guidance
- FDA's recommendations for designing, testing, and labeling medical devices, including IVDs, that lay users will operate at home or in other non-clinical settings.
Final guidance · 2014
Home-Use Device Design Guidance
- FDA's description of how reviewers decide whether a new device is substantially equivalent to a legally marketed predicate, the core question in every 510(k).
Final guidance · 2014
510(k) Substantial Equivalence Guidance
- FDA's guidance on the voluntary Q-Submission program, through which sponsors obtain written feedback or meetings on planned studies and submissions, including Pre-Submissions.
Final guidance · 2025
Q-Submission (Pre-Sub) Guidance
- FDA's enforcement-discretion policy allowing certain IVD studies to use leftover, de-identified human specimens without informed consent, while still requiring IRB review.
Final guidance · 2006
Leftover Specimen Consent Guidance
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