Question 1

What is an early feasibility study for medical devices?

Accepted Answer

An Early Feasibility Study (EFS) is a limited clinical investigation conducted early in a device’s development to assess basic safety and device function in a small number of subjects (typically 5–15). The FDA permits EFS outside the US under 21 CFR 812.28, and data is accepted for IDE and 510(k) submissions.

Question 2

How long does an early feasibility study take in Latin America?

Accepted Answer

bioaccess® completes early feasibility studies in 9–12 months in Latin America, compared to 12–24 months in the US or EU — enabling faster design iteration while generating FDA-acceptable safety data.

Question 3

How much does an early feasibility study cost?

Accepted Answer

A 5-patient EFS through bioaccess® costs approximately $200,000–$300,000 in Latin America, compared to $500,000–$750,000 in the US. A 10-patient EFS ranges from $300,000–$400,000 versus $750,000–$1M in the US.

Early Feasibility Studies (EFS) for Medical Devices — bioaccess®

Service Description

Key Features