Question 1

Does the FDA accept clinical trial data generated in Latin America?

Accepted Answer

Yes. The FDA accepts foreign clinical data under 21 CFR 812.28 (medical devices) and 21 CFR 312.120 (drugs and biologics) provided studies follow ICH E6 Good Clinical Practice, the data is available for FDA inspection, and informed consent meets FDA standards. bioaccess® has supported multiple clients through successful FDA submissions using LATAM FIH data.

Question 2

Which FDA pathways accept data from Latin American first-in-human studies?

Accepted Answer

Latin American FIH data supports: IDE (Investigational Device Exemption) applications for US pivotal trials, 510(k) and De Novo submissions as part of a multi-study clinical evidence package, Breakthrough Device Designation applications (Axoft received FDA BDD using Colombia FIH data), and Pre-Submission meetings with FDA to align on data acceptance before initiating the LATAM study.

Question 3

What GCP standards apply to clinical trials in Latin America?

Accepted Answer

All bioaccess® studies follow ICH E6(R2) Good Clinical Practice. Regulatory authorities in Colombia (INVIMA), Panama (MINSA), Mexico (COFEPRIS), and Brazil (ANVISA) require GCP compliance as a condition of approval. Study sites hold GCSA (Global Quality Standard for Research) certification. Data and monitoring standards are equivalent to US/EU studies.

Question 4

Has bioaccess® data been used in actual FDA submissions?

Accepted Answer

Yes. Named examples include: Axoft (brain-computer interface, Colombia FIH → FDA Breakthrough Device Designation), PAVmed/PortIO (intraosseous vascular access, Panama FIH → FDA submission), enVVeno Medical (venous insufficiency, Colombia → US pivotal trial), Mitralign (acquired by Edwards Lifesciences), and ClarVista Medical (acquired by Alcon). The acquisition outcomes validate FDA acceptance of bioaccess® data.

Question 5

Do I need to notify the FDA before running a FIH study in Latin America?

Accepted Answer

For medical devices, no FDA notification is required before initiating a FIH study outside the US — the FDA gets involved when you submit data for a US application. For drugs and biologics, an IND (Investigational New Drug application) is generally required even for foreign studies. bioaccess® recommends a Pre-Sub meeting with FDA before initiating any LATAM FIH study to align on data acceptance and avoid surprises.

Does the FDA Accept Clinical Trial Data from Latin America?