Documentation · Regulatory pathway

FDA 510(k)

The most common US route to market for moderate-risk devices: show the FDA that a new device is substantially equivalent to one already legally marketed.

Formal name

Premarket Notification

Legal basis

Section 510(k) of the Federal Food, Drug, and Cosmetic Act; 21 CFR Part 807, Subpart E

Applies to

Most Class II devices and some Class I devices

Outcome

A “substantially equivalent” letter. The device is cleared, not approved

Review goal

90 FDA days. Time spent waiting for the submitter to answer questions does not count

Format

Electronic submission using the eSTAR template, required since 1 October 2023

In short

A 510(k) is a comparison. The submitter chooses a predicate, a device already legally on the US market, and shows that the new device has the same intended use and either the same technological characteristics, or different ones that raise no new questions of safety and effectiveness and are shown to be at least as safe and effective. If there is no suitable predicate, the routes are De Novo classification for novel devices of low to moderate risk, or premarket approval (PMA) for Class III.

Three types

• Traditional. The standard submission.
• Special. For a change to the manufacturer’s own cleared device, where design controls and well-established methods are enough to evaluate the change. The review goal is 30 days.
• Abbreviated. Relies on FDA guidance, special controls or recognized consensus standards to shorten the evidence.

What goes in

• The comparison. Device description, indications for use, and the substantial equivalence discussion against the predicate.
• Performance testing. Bench testing, and animal or clinical data where needed. Electrical safety and EMC (IEC 60601), biocompatibility and sterilisation as they apply.
• Software documentation. At the Basic or Enhanced level set by the FDA’s 2023 guidance on device software functions. Enhanced applies when a software failure could lead to a hazardous situation with a probable risk of death or serious injury, judged before risk controls. Both levels include a software description, risk management file, requirements specification, architecture, a summary of testing, the version history and the list of unresolved anomalies. Enhanced adds design specifications and unit and integration test detail.
• Cybersecurity. For devices that include software and can connect to the internet, section 524B of the Act has required cybersecurity information in the submission since March 2023: a plan for handling vulnerabilities after release, evidence of secure development processes, and a software bill of materials.
• Labelling.

On a software project

• The submission is assembled from design control outputs. If the trace matrix, risk file and test reports are produced as the work is done, the submission is compilation rather than reconstruction.
• The version tested is the version described. Freeze the software before formal verification, and assess every unresolved anomaly for its effect on safety.
• Ask first. A Pre-Submission (Q-Sub) meeting gets FDA feedback on the predicate, the test plan or the documentation level before the submission is written.
• Plan for more than 90 days. The goal counts FDA review time only. Requests for additional information stop the clock, so elapsed time is usually longer.
• Changes after clearance need a documented decision. FDA guidance sets out when a software change requires a new 510(k). Record the assessment whichever way it goes. A Predetermined Change Control Plan cleared with the device can authorise specific planned changes in advance.

Worth knowing

• “Cleared” and “approved” are different things. Approval refers to PMA.
• A 510(k) does not replace quality system obligations. 21 CFR Part 820, establishment registration and device listing still apply.
• Decision letters and summaries are public in the FDA’s 510(k) database, which is the practical way to research predicates.

Official sources

• FDA: Premarket Notification 510(k)
• FDA: eSTAR Program
• FDA guidance: Content of Premarket Submissions for Device Software Functions
• FDA 510(k) database

A summary for orientation. It is not regulatory or legal advice, and it is no substitute for the standard or regulation itself. Requirements change: confirm the current edition before relying on anything here. Last reviewed November 2026.