FDA-Compliant Respiratory Rate Device Studies
Respiratory rate is one of the four core vital signs — and the clinical validation of devices that measure it demands the same rigor as any other FDA-regulated monitor. At Vital Signs Research Group, we conduct respiratory rate testing and respiratory rate monitoring validation studies at our San Francisco clinical research facility, helping device manufacturers build the clinical evidence needed for FDA 510(k) submissions.
From wearable respiratory sensors to continuous monitoring systems, we design custom clinical protocols that match your device’s intended use, study population, and regulatory pathway.
Our respiratory rate testing studies are conducted in alignment with applicable FDA guidance and ISO standards for non-significant risk devices. Each study is reviewed and approved by our external IRB (Advarra) and executed in full compliance with ISO 14155, FDA 21 CFR 50, and FDA 21 CFR 812.
We recruit from a broad pre-screened participant database, giving us the flexibility to enroll diverse study populations that meet FDA requirements for representative distribution. Our team of registered nurses and clinical research coordinators ensures every study day runs with precision and full protocol compliance.
A well-designed respiratory rate monitoring validation study should include controlled testing across the full clinically relevant range of respiratory rates, reference measurement pairing for accuracy validation, a diverse participant cohort meeting regulatory requirements, complete clinical data documentation, and a study report formatted for regulatory submission. (confirm with client: specific reference measurement method used for respiratory rate studies)
Whether your device uses optical sensors, impedance plethysmography, or another measurement modality, we have the clinical expertise to build a study around it.
Contact us today to discuss your respiratory rate testing study — we’ll design a protocol that gets your device to clearance efficiently and accurately.