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    513(g) Request for Information

    Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    A 513(g) submission asks CDRH for FDA's opinion on the classification and regulatory requirements applicable to a specific product. Responses are non-binding but heavily relied upon by sponsors of borderline products.

    What this means in practice

    Useful for software-only products, combination products, and wellness devices where the 'is-it-a-device?' answer drives the entire regulatory plan.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    FDA·2European Commission·1
    1. 1
      FDA 513(g)
      Needs review
      FDAfda.gov
    2. 2
      FDA - Medical Devices
      Verified
      FDAfda.gov
    3. 3
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu

    Inline markers like [1] jump to the matching reference above.