Since October 1, 2023, 510(k)s must be submitted as eSTARs unless exempted, and FDA screens each one within 15 days instead of running a classic Refuse to Accept (RTA) review. The screen starts once your user fee is paid, and checks that your answers are accurate and that each applicable question has a relevant attachment.
Key takeaways
- In FDA's data, 8.67% of 510(k)s that completed a first screening in fiscal year 2026, through June 30, failed it, up from 5.40% in fiscal year 2024.
- We measured FDA's data by review office: the office for dental and ophthalmic devices had the highest rate, 16.17% so far in fiscal year 2026.
- Screening starts only after the user fee is paid: $28,653, or $7,163 for a qualified small business, for 510(k)s FDA receives from October 1, 2026.
- An eSTAR fails screening when an answer is inaccurate, or when none of the attachments to a question is relevant.
- After a failed screen, you have 180 days to send a complete replacement eSTAR, or FDA considers the 510(k) withdrawn.
Does the RTA checklist still apply to 510(k)s?
Not to eSTAR submissions, and today every original 510(k) must be an eSTAR. FDA says a properly prepared eSTAR should be a complete submission, so it does not expect eSTARs to go through an RTA review [2, 3]. Instead, FDA scans them for viruses and runs a technical screening [3].
The exemptions do not cover new 510(k)s. FDA exempts only follow-up items from eSTAR, such as certain amendments, appeals and withdrawal requests [2]. FDA also says it does not intend to grant waivers, because every submitter should be able to use eSTAR [2].
| Classic RTA review | eSTAR technical screening | |
|---|---|---|
| Applies to | 510(k)s not sent as eSTARs. FDA's exemptions cover follow-up items, not original 510(k)s [2] | 510(k)s sent as eSTARs, required since October 1, 2023 [2, 3] |
| What FDA checks | Completeness, against the acceptance checklist for a Traditional, Abbreviated or Special 510(k) [1, 7] | Accurate answers, and at least one relevant attachment per applicable attachment question [2] |
| Timing | Within 15 calendar days of receipt [1] | Within 15 days of receipt [2] |
| If it fails | An RTA hold, with a list of missing elements [1, 4] | A technical screening hold, notified by email [2] |
| Deadline to fix | 180 days, or the 510(k) is considered withdrawn [1] | 180 days, or the 510(k) is considered withdrawn [2] |
The RTA checklists still show what a complete 510(k) looks like. FDA's RTA guidance, last updated on April 21, 2022, includes acceptance checklists for Traditional, Abbreviated and Special 510(k)s [1, 7]. Our guide to acceptance review and Refuse to Accept explains the process in brief.
How often do 510(k)s fail the first screen?
In fiscal year 2026 through June 30, 8.67% did. FDA's performance report counts the 510(k)s that were not accepted, or that failed technical screening, on their first cycle [5]:
| Fiscal year | 510(k)s that completed a first screening | Not accepted or failed on the first cycle | Rate |
|---|---|---|---|
| 2023 | 3,806 | 781 | 20.52% |
| 2024 | 3,501 | 189 | 5.40% |
| 2025 | 3,905 | 281 | 7.20% |
| 2026, through June 30 | 2,562 | 222 | 8.67% |
Source: FDA, MDUFA V Performance Report for the quarterly meeting of August 25, 2026, Table 6.1 [5]. A completed screening means the 510(k) passed, was deemed to pass at day 15, or failed. FDA's rate leaves out 510(k)s closed before screening and, for 2026, 173 still in screening on June 30. Excludes third-party reviews.
The rate fell sharply in the first year of mandatory eSTAR. Fiscal year 2024 began on October 1, 2023, the date eSTAR became required [2, 5]. The rate dropped from 20.52% to 5.40% that year [5].
It has risen every year since. It reached 7.20% in fiscal year 2025 and 8.67% in the first three quarters of fiscal year 2026 [5]. That is 222 510(k)s stopped at the first screen in nine months [5].
Some device areas fail more often. We measured the same rate for each of CDRH's eight review offices, using the office tables in FDA's report [5]:
| FDA review office | Fiscal year 2025 | Fiscal year 2026, through June 30 |
|---|---|---|
| Ophthalmic, anesthesia, respiratory, ENT and dental (OHT1) | 13.03% | 16.17% |
| Cardiovascular (OHT2) | 9.54% | 11.95% |
| Neurological and physical medicine (OHT5) | 9.50% | 11.97% |
| Surgical and infection control (OHT4) | 6.83% | 7.92% |
| Gastrorenal, ObGyn, general hospital and urology (OHT3) | 5.40% | 5.88% |
| Orthopedic (OHT6) | 4.95% | 5.62% |
| In vitro diagnostics (OHT7) | 4.69% | 3.26% |
| Radiological health (OHT8) | 3.41% | 4.61% |
FDA's report does not give the reasons behind these rates, and each office reviews a different mix of devices. Still, if you make dental or ophthalmic devices, check your eSTAR with extra care.
What is on the 15-day screening checklist?
Work through these 14 checks before you submit. Each comes from an FDA source.
Fees and timing
- Confirm which fiscal year your fee falls in. FDA charges the fee rate for the date it receives your 510(k), not the date you send it [6]. From October 1, 2026, the standard 510(k) fee is $28,653 [6].
- Apply for small business status early. A business with gross receipts or sales of $100 million or less, including affiliates, may pay the reduced fee of $7,163 [6]. You must submit the qualifying materials at least 60 days before the fee is due, and small business status lasts one fiscal year [6]. If you submit before FDA finds that you qualify, you must pay the full fee [6]. Since November 1, 2024, Small Business Requests must go through the CDRH Portal [8].
- Get a tax certification if you are outside the US. A foreign business needs a National Taxing Authority Certification bearing the official seal of the tax authority in its home country [6]. Each foreign affiliate needs one too [6].
- Pay the fee before you submit. FDA begins screening only after the user fee is paid [1, 2]. It first checks that the right fee was received and that a valid eSTAR was provided [4].
Building the eSTAR
- Use the current major version of eSTAR. If you use an older major version, you may receive additional information requests about the changes, unless they do not affect your device [3].
- Edit in a program that can save it. FDA lists Adobe Acrobat Pro, PDF-XChange Editor 10.2.0 or higher, and Foxit PDF Reader 12.1 or higher [3]. Adobe Acrobat Reader opens eSTAR but cannot save changes or add attachments [3].
- Choose the right 510(k) type. FDA may check your submission type during screening [9]. If a Special 510(k) should have been a Traditional 510(k), for example, FDA places it on hold until the correct type arrives [9].
- Answer every drop-down question accurately. An inaccurate answer can hide questions that should appear, and FDA says it may lead to an early hold [3]. FDA says it intends to verify the accuracy of your responses [3].
- Write everything in English. FDA's acceptance checklist asks for all supporting content in English, including translations of test reports and literature articles [1].
- Address earlier FDA feedback. If FDA gave feedback on the same device before, for example in a Pre-Submission, FDA's acceptance criteria expect your 510(k) to address it [1].
Attachments
- Attach at least one relevant file to each applicable attachment question. FDA's example: if your device has software, attach a Software Description in answer to the Software Description question [2]. An attachment that is not relevant to its question does not count [3].
- Do not attach the built-in forms. The Indications for Use form (FDA 3881), the cover sheet (FDA 3514) and any Declaration of Conformity are built into eSTAR [3]. If you create your 510(k) Summary in eSTAR, you do not need a separate one [3].
- Use accepted, readable files. eSTAR rejects zip files automatically, and FDA discourages password-protected PDFs [3]. Through the CDRH Portal, each attachment can be up to 1 GB and the whole eSTAR up to 4 GB, and eSTAR rejects attachment names longer than 124 characters [3]. FDA also scans submissions for viruses [3].
Submitting
- Check for "eSTAR COMPLETE" and send it through the CDRH Portal. The Portal does not accept an eSTAR that still shows "eSTAR INCOMPLETE" [3]. Submissions received before 4 PM Eastern Time on a US business day are processed the same day, and later ones on the next business day [8].
Our eSTAR template guide covers how to fill in each section. Complizen's Submission Builder runs pre-flight checks against FDA's Refuse to Accept criteria and exports your submission as an eSTAR.
What happens if your 510(k) fails screening?
FDA emails you, identifies the incomplete information and places your 510(k) on hold [2]. The hold lasts until FDA receives a complete replacement eSTAR [2].
You have 180 days. If FDA does not receive a complete replacement eSTAR within 180 days of its notice, it considers the 510(k) withdrawn and closes it [2]. You would then need to submit a new 510(k) [4].
Update your original eSTAR. Once FDA sends the acknowledgment letter for your submission, it is tied to the eSTAR version you used [3]. When you respond to a technical screening hold, update your original eSTAR rather than switching to a newer version [3]. Choose the Additional Information option under Application Sub-Type, and follow the instructions built into the template [3].
A passing 510(k) loses no time. For a submission that passes technical screening, FDA's review clock starts on the day FDA received it [2].
No decision in 15 days counts as a pass. If FDA records no screening decision by the end of day 15, the 510(k) is deemed to have passed [5]. In fiscal year 2025, this happened to 40 510(k)s [5].
After screening, the substantive review may bring its own questions. Our guide to FDA additional information requests explains that stage.
What happens under the classic RTA review?
Few new 510(k)s go through it now, because an original 510(k) must be an eSTAR [2]. Where FDA runs the classic acceptance review, it should be completed within 15 calendar days of receipt, and it begins only after the user fee is paid [1]. An RTA decision needs a supervisor's agreement before FDA sends it [1].
The review has three possible results [4]:
| Result | What it means |
|---|---|
| Accepted | The 510(k) moves to substantive review |
| Refused to accept (RTA) | The 510(k) goes on RTA hold, with a list of missing elements |
| No decision within 15 calendar days | The 510(k) moves to substantive review |
Send only what FDA asked for. Respond under the original 510(k) number [1]. You do not need a new submission or a new user fee [1]. FDA reviews each response within a new 15-day cycle [1].
You also have 180 days. If FDA does not receive a complete response within 180 days of the RTA notice, it considers the 510(k) withdrawn [1].
You can ask for a second look. If you disagree with an RTA decision, you can ask a supervisor to review it under 21 CFR 10.75 [11]. FDA must receive the request within 60 days of the decision [11]. After an RTA, the review clock starts on the date FDA received the submission or information that led to acceptance [1].
What should manufacturers outside the US check first?
- English. Test reports and literature in another language need English translations [1]. If most of a submission is not in English, FDA may ask you to resend all of it after an RTA, not just the missing items [1].
- Tax certification. Your National Taxing Authority Certification must show gross receipts in US dollars and your local currency, the exchange rate used and the dates covered [6]. Allow 60 days before the fee is due [6].
- Time zones. The CDRH Portal processes submissions received after 4 PM Eastern Time on the next business day [8]. FDA sends screening notices by email [2], which may arrive outside your working hours, so the contact person in your eSTAR should check email every day.
- Registration and US agent. A foreign establishment must be registered, with a US agent, before its device is imported [10]. That is required before import, not before 510(k) clearance. See our FDA US agent guide.
See our FDA user fees page for all current fees.
Frequently asked questions
Does FDA still use the RTA checklist?
Rarely for new 510(k)s. Since October 1, 2023, an original 510(k) must be an eSTAR, and FDA does not expect eSTARs to undergo an RTA review. FDA's eSTAR exemptions cover follow-up items, such as amendments. The RTA checklists remain a useful list of what a complete 510(k) contains.
Can I dispute an RTA decision?
Yes. FDA lists 510(k) Refuse to Accept letters among the decisions you can ask a supervisor to review under 21 CFR 10.75. FDA must receive the request within 60 days of the decision. FDA's list does not name technical screening holds, though it says its examples are not the only ones.
How long does technical screening take?
FDA anticipates completing technical screening within 15 days of receiving your eSTAR. If FDA records no screening decision by the end of day 15, the 510(k) is deemed to have passed. Screening begins only after your user fee has been paid.
Why do eSTARs fail technical screening?
FDA names two failure types: an inaccurate answer to any question, or attachments that are not relevant to their question. Inaccurate drop-down answers are a known risk, because they can hide questions that should appear. FDA does not publish a ranking of failure reasons.
How many 510(k)s fail the first screen?
In fiscal year 2025, 7.20% of the 510(k)s that completed a first screening at CDRH were not accepted or failed it. From October 1, 2025 to June 30, 2026, the rate was 8.67%. In fiscal year 2023, before eSTAR was required, it was 20.52%.
What happens after a technical screening hold?
FDA emails you and identifies the incomplete information. Your 510(k) stays on hold until FDA receives a complete replacement eSTAR. If none arrives within 180 days of the notice, FDA considers the 510(k) withdrawn and closes it, and you would need a new 510(k).
Should I use the newest eSTAR version for my hold response?
No. Once FDA sends the acknowledgment letter for your original submission, your 510(k) is tied to that eSTAR version. FDA asks you to update your original eSTAR when responding to a technical screening or additional information request, rather than switching to a newer version.
Does FDA's review clock run while my 510(k) is on hold?
No. For a 510(k) that passes technical screening, the clock starts on the day FDA received it. After an RTA, it starts on the date FDA received the information that led to acceptance. A submission of the wrong 510(k) type starts its clock when the correct type arrives.
When is the 510(k) user fee due?
Before screening starts, because FDA begins screening only after the fee is paid. The amount depends on the date FDA receives your 510(k). From October 1, 2026, the fee is $28,653, or $7,163 for a qualified small business. To pay the small business fee, FDA must find that you qualify before you submit.
How do I qualify for the small business 510(k) fee?
Your business, including affiliates, needs gross receipts or sales of $100 million or less for the most recent tax year. Submit the materials at least 60 days before the fee is due, and re-qualify every fiscal year. A foreign business needs a National Taxing Authority Certification from its home country.
Do I need to pay a new user fee after an RTA?
No. FDA says you can send the missing information under the original 510(k) number, and that a new submission and a new user fee are not necessary. If the 510(k) is withdrawn after 180 days, though, you would need to submit a new 510(k).
Do I need to attach Form 3881 or Form 3514 to my eSTAR?
No. The Indications for Use form (FDA 3881), the Premarket Review Submission Cover Sheet (FDA 3514) and any Declaration of Conformity are built into the eSTAR template. FDA says you do not need to provide them separately with your eSTAR.
References
- FDA. Refuse to Accept Policy for 510(k)s. Guidance issued April 21, 2022.
- FDA. Electronic Submission Template for Medical Device 510(k) Submissions. Guidance issued October 2, 2023.
- FDA. eSTAR Program. Content current as of September 21, 2026.
- FDA. 510(k) Submission Process. Content current as of October 3, 2022.
- FDA. MDUFA V Performance Report, for the quarterly meeting of August 25, 2026. Data through June 30, 2026.
- Federal Register. Medical Device User Fee Rates for Fiscal Year 2027, 91 FR 48134. Published July 30, 2026.
- FDA. Acceptance Checklists for 510(k)s. Content current as of April 21, 2022.
- FDA. Send and Track Medical Device Premarket Submissions Online: CDRH Portal. Content current as of December 5, 2025.
- FDA. FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals. Guidance issued October 3, 2022.
- eCFR. 21 CFR 807.40, establishment registration and device listing for foreign establishments. Accessed September 26, 2026.
- FDA. Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A. Guidance issued March 27, 2020.