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): substantial equivalence to a predicate (most Class II)
• De Novo: novel low-to-moderate-risk devices with no predicate
• PMA: high-risk Class III requiring clinical evidence
• IDE: to run a US study of a significant-risk investigational device
• Outside-US FIH data (21 CFR 812.28) can support these when GCP-compliant

FDA acceptance of LATAM data · LATAM regulatory guide