510(k)

Term and legal basis

The 510(k) is the most common route for bringing a medical device to the US market. The name refers to Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act, the US federal law governing food, drugs, and cosmetics). Under it, a manufacturer must submit a notification, the Premarket Notification, to the FDA at least 90 days before the planned market introduction. The procedure is governed by 21 CFR Part 807 Subpart E (“Premarket Notification Procedures”).

In substance, the submission shows that the new device is substantially equivalent to a device that is already legally marketed (Substantial Equivalence). This comparison device is called the predicate device. Equivalent does not mean identical: under 21 CFR 807.100, the device needs the same intended use and either the same technological characteristics or different characteristics that do not raise different questions of safety and effectiveness. The details are described in the entry Substantial Equivalence and Predicate Device.

If the FDA finds the device substantially equivalent, it issues an order that releases the device for distribution (clearance). Before that, it may not be marketed. The 510(k) is also the mechanism through which the FDA classifies new devices: a substantially equivalent device falls into the same class as its predicate, and a device that is not substantially equivalent initially falls into Class III (see FDA device classification). A clearance is expressly not an official approval. Anyone who uses the 510(k) to create the impression of an approval is acting in a misleading way under 21 CFR 807.97.

When a 510(k) is required

Under 21 CFR 807.81, a 510(k) is required in two basic cases:

• First-time market introduction: A manufacturer places a device on the US market for the first time.
• Significant change: A device that is already marketed is changed in design, components, manufacturing process, or intended use in a way that could significantly affect safety or effectiveness, or the intended use changes fundamentally.

Devices for which a Premarket Approval (PMA) is required do not need a 510(k). Many device types are also exempt from the 510(k) by classification regulation. If there is no suitable predicate for a novel device of low or moderate risk, a De Novo request may be considered instead of the 510(k).

Whether a change triggers a new 510(k) is described by the FDA in the guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device” (October 2017). It expressly names changes to the user interface, for example to the presentation of alarms, the layout of the control panel, the presentation of information, or the users' workflow. For changes to the labeling as well, manufacturers should assess whether they could cause human factors or usability problems.

Traditional, Special, and Abbreviated 510(k)

The FDA distinguishes three types of submission:

• Traditional 510(k): the original form under 21 CFR Part 807. It is possible for any initial submission and for any change to a cleared device.
• Special 510(k): for changes to the manufacturer's own legally marketed device. The prerequisite is that the methods for evaluating the change are established and that the results can be reviewed in the form of a summary or risk analysis. The Special 510(k) relies on the results of design controls (see QMSR and design controls). If the FDA considers a Special 510(k) unsuitable, it converts it into a Traditional 510(k).
• Abbreviated 510(k): The manufacturer submits summaries that rely on FDA guidances, on special controls for the device type, or on recognized standards.

According to the FDA, it generally reviews Traditional and Abbreviated 510(k)s within 90 days of receipt and Special 510(k)s generally within 30 days, in each case subject to the acceptance review (as of October 2026).

Content of a submission

The minimum content is set out in 21 CFR 807.87. It includes, among other things:

• device name, classification of the device,
• the proposed labeling, which describes the device, its intended use, and the instructions for use,
• a comparison with comparable devices on the market, with data supporting this comparison,
• for significant changes, data showing that the manufacturer has assessed the effects on safety and effectiveness,
• a 510(k) Summary under 21 CFR 807.92 or a 510(k) Statement,
• the declaration that all information is true and complete to the best of the manufacturer's knowledge.

The 510(k) Summary names the predicate, describes the device and its intended use, and compares the technological characteristics. If substantial equivalence relies on performance data, it summarizes the nonclinical and clinical testing. How intended use and indications are worded is described in the entry Indications for Use. Submission is electronic and, since October 1, 2023, generally uses the FDA template eSTAR (as of October 2026).

Review by the FDA

The law requires the FDA to decide on the submission no later than 90 days after receipt. An acceptance review comes first. Under 21 CFR 807.100, the FDA can

• declare the device substantially equivalent (Substantially Equivalent, SE),
• declare it not substantially equivalent (Not Substantially Equivalent, NSE),
• request additional information,
• postpone the decision until a statement on the financial interests of clinical investigators is submitted, or
• notify the manufacturer that no 510(k) is required.

Questions about the approach, such as the choice of predicate or planned testing, can be clarified with the FDA in advance through a Pre-Submission.

Human factors information in the 510(k)

Which human factors information a 510(k) should contain is described by the FDA in the guidance “Content of Human Factors Information in Medical Device Marketing Submissions”, version dated May 29, 2026. It applies to 510(k), De Novo, PMA, and HDE submissions and supplements the FDA human factors guidance. For the 510(k), substantial equivalence remains decisive. According to the guidance, human factors information is only one component of the assessment. For submissions made before August 1, 2026, the FDA generally does not yet expect the newly recommended content.

At the core of the guidance is a risk-based decision tree that assigns each submission to one of three HF Submission Categories. The basis is the use-related risk analysis (URRA). IEC 62366-1 speaks of hazard-related use scenarios, the FDA of critical tasks: tasks whose incorrect or omitted performance would or could cause serious harm.

• Decision points A and B: If the submission concerns a change to an already cleared device and the user interface, intended users, uses, use environment, training, and labeling remain unchanged, Category 1 applies. A conclusion and a brief summary are sufficient.
• Decision point C: If the URRA shows no critical tasks, and for changes no new or affected critical tasks, Category 2 applies. The manufacturer justifies this and submits, among other things, descriptions, the URRA, and an overview of known use problems.
• Decision point D: If there are critical tasks, the use history and complexity of the user interface as well as the effectiveness of existing risk controls determine whether validation data are needed. If a rationale suffices, it remains Category 2. Otherwise Category 3 applies, with a full HFE/UE report including human factors validation.

For the 510(k), the comparison with similar devices is particularly useful. The guidance names the comparison of labeling, a comparative task analysis, and a physical comparison as means of identifying differences between user interfaces and shared risks. According to the guidance, validation data are likely to be needed for complex user interfaces and for device types with known use errors, such as infusion pumps. The same can apply if the device differs markedly from comparable devices, new safety signals exist, or the potential severity of harm has increased.

Two examples from the guidance show the range: a new finger pulse oximeter without alarms has no critical tasks according to the URRA and falls into Category 2. A new injection device with a novel user interface falls into Category 3. If it is unclear whether a rationale suffices instead of a validation test, the FDA recommends a Pre-Submission. Regardless of the category, the manufacturer should keep its human factors documentation available as part of its quality management system under QMSR and ISO 13485.

Frequently asked questions (FAQ)

Sources

• FDA Guidance: Content of Human Factors Information in Medical Device Marketing Submissions
• FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices
• 21 CFR Part 820, Quality Management System Regulation (QMSR)
• IEC 62366-1:2015+AMD1:2020, Medical devices, Part 1: Application of usability engineering to medical devices
• ISO 13485:2016, Medical devices, Quality management systems, Requirements for regulatory purposes
• Federal Food, Drug, and Cosmetic Act, Section 510 (21 U.S.C. 360), subsections (k) and (n)
• 21 CFR Part 807 Subpart E, Premarket Notification Procedures
• FDA Guidance: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (2014)
• FDA Guidance: The Special 510(k) Program (2019)
• FDA Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (2017)
• FDA: 510(k) Submission Programs
• FDA: Premarket Notification 510(k)

Related terms

• FDA human factors guidance
• HFE/UE report (human factors report)
• Human factors validation testing
• Use-related risk analysis (URRA)
• Critical task
• Intended use
• Labeling

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