Key takeaways. bioaccess® runs first-in-human (FIH) and early-feasibility (EFS) clinical evaluations of Software-as-a-Medical-Device (SaMD) and digital health products in Latin America. Sponsors use LATAM to generate out-of-US (OUS) clinical evidence quickly and bridge that data back into US submissions under 21 CFR 812.28, on the same well-established pathway used for hardware devices.
Software intended for a medical purpose that operates independently of a hardware medical device — including diagnostic algorithms, clinical decision support, AI/ML-based diagnostic tools, therapeutic apps, and remote monitoring platforms.
Ethics-committee and health-authority approvals in Latin America land faster than in the US, and OUS data can support US submissions when the study is conducted under ISO 14155 (device GCP) with appropriate ethics oversight. Same framing as our Surgical & Medical Robotics CRO pathway: OUS data supports FDA Pre-Sub, IDE, and downstream 510(k)/De Novo/PMA under 21 CFR 812.28.
The same regulation — 21 CFR 812.28 — governs FDA acceptance of foreign clinical data for devices, including software devices. Sponsors align endpoints in a Pre-Submission, run the study in LATAM under ISO 14155 (device GCP) with 21 CFR Part 11-compliant EDC, and submit the resulting data as part of their US regulatory package.
End-to-end FIH/EFS execution: regulatory strategy, ethics and health-authority submissions, site activation, monitoring, and clinical study report — coordinated from Miami HQ with sponsor-facing reporting in U.S. business hours.
Talk to us about your SaMD study · Related: First-in-Human CRO · Early Feasibility Studies · FDA Acceptance