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/EU, 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