What are the FDA regulatory pathways for medical devices?

Medical devices map to FDA pathways by risk class: 510(k) for substantial equivalence (Class II), De Novo for novel low-to-moderate-risk devices, and PMA for high-risk Class III. Early first-in-human data from Latin America can feed the chosen pathway; bioaccess® confirms the route via an FDA Pre-Submission.

From the Global Trial Accelerators™ podcast with Kristen Mittal (Mittal Consulting): watch the episode.

The main FDA device pathways

• 510(k): demonstrate substantial equivalence to a legally marketed predicate (most Class II)
• De Novo: novel low-to-moderate-risk devices with no predicate
• PMA: high-risk Class III devices requiring clinical evidence of safety and effectiveness
• IDE: needed to run a US clinical study of a significant-risk investigational device
• Outside-US first-in-human data (21 CFR 812.28) can support these submissions when GCP-compliant

Frequently asked questions

What's the difference between 510(k), De Novo, and PMA?

510(k) clears a device by showing substantial equivalence to an existing legally marketed predicate (typically Class II). De Novo is for novel low-to-moderate-risk devices that have no predicate. PMA is the most stringent pathway, for high-risk Class III devices, and requires clinical evidence of safety and effectiveness.

Can first-in-human data from Latin America support an FDA device submission?

Yes. Under 21 CFR 812.28, the FDA accepts data from investigational device studies conducted outside the US to support an IDE, 510(k), De Novo, or PMA when the study meets Good Clinical Practice and the FDA can validate the data. bioaccess® designs LATAM studies to be FDA-acceptable.

How do you choose the right FDA pathway?

Pathway depends on device risk class, novelty, and whether a predicate exists. The most reliable way to confirm it is an FDA Pre-Submission (Pre-Sub), where the agency weighs in on classification, pathway, and evidence expectations before you invest in a study.

Primary regulatory sources

• FDA — Acceptance of Data from Clinical Investigations for Medical Devices
• 21 CFR 812.28 — Acceptance of data from clinical investigations conducted outside the United States
• 21 CFR 312.120 — Foreign clinical studies not conducted under an IND

Reviewed by Julio G. Martinez-Clark, Co-Founder & CEO, bioaccess®. Last reviewed: July 9, 2026.

Related resources

• FDA acceptance of LATAM data
• LATAM regulatory guide
• Clinical trials in Mexico
• Case study: Sparta Biomedical (FDA Breakthrough Device via LATAM data)
• Book a strategy call