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    Regulatory

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

    In one line
    FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
    Definition
    A 510(k) is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that a device to be marketed is at least as safe and effective - that is, substantially equivalent - to a legally marketed device that is not subject to premarket approval (PMA).
    Why it matters
    Most Class II devices in the United States reach the market through the 510(k) pathway. A clearance (often called 'K number') is required before commercial distribution. Choice of predicate, indications for use, and performance testing are central to a successful submission.
    Common pitfalls
    • •Treating 510(k) clearance as 'FDA approval' - it is a clearance based on equivalence, not an approval.
    • •Choosing a predicate with materially different indications, technology, or performance.
    • •Underestimating cybersecurity content now expected for software-containing devices.
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    Regulatory

    Premarket Approval(PMA)

    In one line
    FDA's most stringent device marketing application, required for high-risk Class III devices.
    Definition
    Premarket Approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. PMA is the most stringent type of device marketing application required by the FDA.
    Why it matters
    PMA submissions must include valid scientific evidence, typically from clinical investigations, that the device is safe and effective for its intended use. They also undergo facility inspection prior to approval.
    Common pitfalls
    • •Assuming a 510(k) pathway will work for novel high-risk devices.
    • •Underestimating the manufacturing inspection component (PAI).
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    Why compare MedTech terms side by side?

    MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

    Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

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    MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.