FDA 510(k) Submission Checklist: Every Section You Need

FDA requires all 510(k) submissions to be filed using the eSTAR (electronic Submission Template and Resource) format. eSTAR is a fillable PDF that structures your submission into standardized sections. An incomplete or incorrectly assembled eSTAR will result in a Refuse to Accept (RTA) — resetting your clock before substantive review even begins.

This checklist covers every section of a standard 510(k). Device-specific requirements (software, sterility, biocompatibility) add additional sections depending on your device type.

Section 1: Device Description

This section sets the scope of your submission. The intended use statement you write here must be consistent with your labeling, your predicate comparison, and your performance testing. Any inconsistency between Section 1 and another section is a common AI trigger.

Include a clear description of how the device works, all components and accessories, the materials that contact the patient (if any), and how the device is used in a clinical or home setting. Photographs and diagrams are expected for most device types.

Section 2: Substantial Equivalence Discussion

This is the core of your 510(k). You must identify your predicate device(s), explain why you selected them, and demonstrate that your device has the same intended use and either the same technological characteristics or different characteristics that do not raise new safety or effectiveness questions.

If your predicate is itself a 510(k)-cleared device, you should trace the predicate chain back to a preamendment device or a device that was cleared under a recognized standard. FDA reviewers look at predicate chain integrity.

Section 4: Predicate Device Comparison Table

This is the most scrutinized section for many device types. The comparison table must cover every technological characteristic that differs between your device and the predicate. For each difference, you must either argue it is not a difference that raises new questions, or provide performance data that demonstrates safety and effectiveness despite the difference.

A weak Section 4 is the single most common reason 510(k)s receive AI requests. Spend disproportionate time here.

Common Refuse to Accept triggers

Before you file: the pre-submission check

Before filing, run through this list:

• Does your intended use statement match identically across Sections 1, 3, and the Indications for Use form?
• Is every technological difference from your predicate addressed in Section 4 with data or a justified rationale?
• Are all test reports referenced in Section 5 actually included as attachments?
• If your device contains software, is Section 8 complete including a cybersecurity section?
• Is your predicate a cleared 510(k) device (not a 510(k)-exempt or PMA device)?
• Does your labeling include all required elements per 21 CFR Part 801?