An early feasibility study in Panama runs as a first-in-human device investigation under Ley 84 and Decreto Ejecutivo 21 — no separate IDE/IND filing, a dedicated device-trial channel at MINSA, and ethics clocks with hard deadlines. bioaccess® designs Panama EFS work for the FDA conversation from day one.
An early feasibility study (EFS) in Panama is a first-in-human device investigation conducted under Ley 84 of 14 May 2019 and Decreto Ejecutivo 21 of 23 April 2026. No separate Investigational Device Exemption (IDE) filing is required in Panama — the study authorizes through the MINSA/ethics pathway, and the EFS is designed from the protocol stage for FDA submission under 21 CFR 812.28.