An early feasibility study in El Salvador runs as a first-in-human device investigation under the SRS, with centralized CNEIS ethics and a realistic 3–5 month submission-to-first-patient envelope. bioaccess® builds the EFS for the FDA conversation — and tells you the honest clock up front.
An early feasibility study (EFS) in El Salvador is a first-in-human device investigation conducted under the Superintendencia de Regulación Sanitaria (SRS) — autonomous since August 2024 — with centralized ethics review at the Comité Nacional de Ética de la Investigación en Salud (CNEIS). The two submissions run in parallel on one timeline.