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    Device Reclassification Petition

    Formal request to FDA to move a device type from one classification (I, II, or III) to another, either down-classifying or up-classifying.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed June 20, 2026

    Definition

    A reclassification petition is a formal submission asking FDA to change the regulatory classification of a generic type of device. Section 513(e) of the FD&C Act authorizes FDA-initiated reclassification; Section 513(f)(3) authorizes manufacturer-initiated petitions. Petitions must include valid scientific evidence showing that the device type warrants a different classification, typically that risks can be adequately controlled by general or special controls (down-classification from III to II) or that existing controls are insufficient (up-classification).
    What the regulation says
    FD&C Act §513(e) and §513(f)(3); 21 CFR 860.130 (FDA-initiated) and 21 CFR 860.132 (manufacturer-initiated). FDA published the 'Reclassification of Medical Devices' guidance in 2019.

    What this means in practice

    Reclassification is uncommon but strategically powerful. Down-classifying a Class III device type to Class II eliminates the PMA burden for the entire device class, affecting every competitor. FDA periodically reclassifies device types based on accumulated post-market evidence (e.g., reclassification of certain external defibrillators, some surgical staplers). Manufacturer-initiated petitions typically come from industry consortia rather than individual companies because the benefits accrue to all competitors.
    Common pitfalls
    • •Treating a reclassification petition as a substitute for a 510(k) or De Novo, petitions reclassify the entire generic type, not individual products.
    • •Underestimating the evidence bar, FDA requires comprehensive scientific evidence about the device type's risk profile across the market.
    • •Ignoring the public comment and Federal Register process, reclassifications go through formal rulemaking.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-06-20
    FDA·1eCFR·1IMDRF·1
    1. 1
      Reclassification of Medical Devices Guidance
      Bot-blocked
      FDAfda.gov
    2. 2
      21 CFR Part 860 Subpart C
      Verified
      eCFRecfr.gov
    3. 3
      IMDRF Documents
      Verified
      IMDRFimdrf.org

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