Source-linked research methods
FDA medical-device research guides
Practical methods for searching public FDA and CMS records without dropping the context that makes the evidence interpretable. Each guide links to primary sources and a corresponding Constat research surface.
510(k) predicate-device research
How to Find and Compare FDA 510(k) Predicate Devices
Find possible FDA 510(k) predicate devices by product code and intended use, then compare technological characteristics, validation evidence, and predicate chains.
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AI medical-device validation
How to Compare AI Medical-Device Validation Evidence
Compare validation studies in FDA AI medical-device summaries without mixing analysis units, tasks, populations, endpoints, or study designs.
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Medical-device postmarket surveillance
How to Search the FDA MAUDE Database Without Misreading It
Search FDA MAUDE medical-device reports by product code and time window while preserving reporting, denominator, causation, and comparability limitations.
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FDA inspection and compliance records
FDA Form 483 vs. Warning Letter: What Each Record Means
Compare FDA Form 483 inspection observations with Warning Letters, including timing, evidentiary meaning, response context, and firm-history research.
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Medical-device market access
Medical-Device Reimbursement: Coding, Coverage, and Payment
Research medical-device reimbursement as three connected but distinct questions: coding, Medicare coverage, and payment methodology.
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