FDA’s Refuse to Accept (RTA) process is an acceptance review—it checks whether your 510(k) submission is complete enough to begin substantive review. FDA’s guidance emphasizes that acceptance is based on objective checklist criteria:
the presence of required elements (or a rationale for omission), not whether the evidence is ultimately persuasive.
Use this as a fast pre-submit “sanity check” to avoid the most common RTA-triggering gaps.
1) Indications for Use (IFU) form is included—and consistent
Missing or inconsistent “Indications for Use” language is a frequent acceptance-review failure because it’s foundational to what FDA is being asked to clear. Before submitting, make sure your IFU language matches across your submission and labeling wherever it appears.
2) 510(k) Summary (or 510(k) Statement) is present
A Traditional 510(k) should include either a 510(k) Summary or a 510(k) Statement as part of the submission package. This is one of those “simple-but-fatal” omissions that can trigger an RTA.
3) Truthful and Accuracy Statement is signed and included
FDA expects a Truthful and Accuracy Statement in a 510(k), and leaving it out is an avoidable RTA item. Confirm it’s signed/dated by the appropriate party and included in the administrative section.
4) Prior submissions are listed (or you explicitly state “none”)
The RTA guidance calls out “Prior Submissions Relevant to the Submission Under Review,” and leaving this unclear can create preventable acceptance-review friction. If there were no relevant prior submissions, state that plainly instead of leaving the section blank.
5) Device description is complete (models, materials, drawings/photos)
FDA expects enough device detail to understand exactly what is being reviewed, including variations/models and descriptive details (often supported by drawings or photos). A thin device description can become an acceptance issue when it prevents the submission from being understood.
6) Principle of operation + key performance specifications are described
FDA’s “content of a 510(k)” expectations include narrative/technical description elements like indications, principles of operation, and other information needed to understand the device. Missing these basics can make the submission hard to review and contribute to an RTA decision if the file can’t be understood.
7) Predicate device is clearly identified (and the SE framing is coherent)
Traditional 510(k)s rely on substantial equivalence to a predicate, and FDA’s content expectations include identifying the legally marketed device (often including the 510(k) number if known). If the predicate is unclear or inconsistently referenced, reviewers may struggle to understand what you’re comparing against early in the process.
8) Proposed labeling is included as final draft (labels + IFU + key warnings)
FDA’s 510(k) content page specifically notes that the labeling submitted should be final draft, and it should include directions for use plus warnings/contraindications/limitations as applicable. Missing labeling elements are a classic “checklist fail” because labeling is explicitly required content.
9) Sterility / reprocessing / shelf-life sections are addressed (when applicable)
If your device is sterile, reprocessed/reusable, or you’re making shelf-life claims, the relevant sections need to be present or clearly marked “N/A” with rationale, consistent with FDA’s objective acceptance checklist approach. A common RTA pattern is skipping an “applicability” section instead of explicitly addressing it.
10) Software (and cybersecurity-relevant) documentation is included (when applicable)
If software is part of your device, you need to include the software-related documentation expected for review, because leaving software content absent or ambiguous creates immediate completeness issues. FDA’s RTA approach again is presence/omission: include it, or clearly justify why it’s not applicable.
