MedTech Terms
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    All pathsRA · Product · 7 terms

    510(k) Fundamentals

    From predicate selection to substantial equivalence to RTA - the core 510(k) toolkit.

    1. 1
      Regulatory

      510(k) Premarket Notification(510(k))

      FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
    2. 2
      Regulatory

      Predicate Device

      A legally marketed device used as the comparator in a 510(k) submission.
    3. 3
      Regulatory

      Substantial Equivalence(SE)

      The legal standard a 510(k) device must meet versus a predicate.
    4. 4
      Regulatory

      Intended Use

      The objective intent of the manufacturer regarding the use of the device.
    5. 5
      Regulatory

      Indications for Use(IFU (statement))

      Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate.
    6. 6
      Regulatory

      Refuse to Accept(RTA)

      FDA administrative decision that a submission is incomplete and won't be substantively reviewed.
    7. 7
      Regulatory

      De Novo Classification Request(De Novo)

      Pathway to classify novel low- to moderate-risk devices that lack a predicate.

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