How to Fill Out and Submit the FDA eSTAR 510(k) Form

To fill out and submit the FDA eSTAR 510(k) form, download the correct eSTAR template from the FDA’s eSTAR Program page, open it in Adobe Acrobat Pro, complete every required field and attachment until the built-in status bar reads “eSTAR Complete,” pay your MDUFA user fee to generate an MD-prefixed payment identification number, and upload the finished PDF through the CDRH Portal. Every 510(k) filed with CDRH or CBER has had to use eSTAR since October 1, 2023, and submissions in any other format are rejected at intake unless you hold a specific exemption.1U.S. Food and Drug Administration. Premarket Notification 510(k)

Pick the Right Template and Open It in the Right Software

The FDA publishes separate eSTAR templates for different device types, and choosing the wrong one is one of the easier ways to stall your filing before it starts. For a 510(k), you need one of two:2FDA. eSTAR Program

  • Non-In Vitro Diagnostic (nIVD) eSTAR, Version 6, for any medical device that is not an IVD.
  • In Vitro Diagnostic (IVD) eSTAR, Version 6, for IVD devices, including Dual 510(k)/CLIA Waiver submissions.

Download the file from the FDA’s eSTAR Program page and save it locally before opening. As of February 2, 2026, both templates were updated to align with the FDA’s Quality Management System Regulation, and later that month all templates incorporated updated Real-World Evidence guidance that took effect February 16, 2026. If you already began working in Version 6.0, you are not required to switch to 6.1.

The template runs on JavaScript and dynamic XML that most free PDF readers cannot handle. The FDA directs users to Adobe Acrobat Pro. Browser viewers, Apple Preview, and other lightweight tools will not render the form correctly and can silently corrupt your data. A known JavaScript bug in some Acrobat Pro versions makes the template noticeably slow; the FDA notes the slowness is not present in FoxIt PDF Reader, PDF-XChange Editor, or Adobe Acrobat Pro 2017. If you switch editors to get around the lag, confirm the finished file validates before you send it.

Fill In the Form Section by Section

Before touching any fields, read the Introduction, Key, FAQ, and Version History sections built into the PDF. They contain field-specific instructions and explain the form’s branching logic, where certain questions only appear after you answer a prior question a particular way.

The template collects information in a structured sequence. Early sections ask for foundational data: your registered contact information, the device’s product code, and its regulatory classification. You will also enter a detailed device description and the indications for use that match the device’s intended purpose. These entries feed how the FDA routes your application to the right review division, so accuracy here matters more than it looks.

Later sections prompt you to upload supporting documents through designated attachment buttons inside the form. Typical attachments for a 510(k) include:

  • Labeling materials: instructions for use, package inserts, and any patient-facing labels.
  • Performance testing data: bench testing results, biocompatibility reports, and comparative data against the predicate device.
  • Sterilization data, required when the device is marketed sterile or when sterilization affects performance.
  • Software documentation for devices with electronic components, including software-level hazard analysis and, where applicable, cybersecurity risk assessments.

Every attachment should be a high-quality, searchable PDF so reviewers can navigate and search the content. Keep the total package under 4 GB and each individual attachment under 1 GB; those are the CDRH Portal’s hard limits.3Food and Drug Administration. Send and Track Medical Device Premarket Submissions Online: CDRH Portal

Get to “eSTAR Complete” Before You Submit

The form’s validation logic monitors required fields as you work. If a section is incomplete or a mandatory attachment is missing, the status bar at the top of the PDF reads “eSTAR Incomplete.” When every field and attachment passes validation, it changes to “eSTAR Complete.”2FDA. eSTAR Program

Do not upload the file while the status still reads incomplete. The FDA will place the submission on hold and email you a screenshot of the unfinished sections. Before closing out of the template, run through the Verification section of the PDF; it is the single best safeguard against a preventable hold.

Pay the User Fee and Get Your MD Number

The FDA will not begin reviewing your submission until the full user fee is paid. For fiscal year 2026 (October 1, 2025 through September 30, 2026), the 510(k) fees are $26,067 for the standard rate and $6,517 for small businesses.4Food and Drug Administration. Medical Device User Fee Amendments (MDUFA): Fees There is no user fee for a 510(k) submitted on behalf of an FDA-accredited third-party reviewer. Small business rates require prior certification through the FDA’s Small Business Determination program, and that certification can take up to 60 days to process, so apply well before you plan to submit.

Before uploading your eSTAR, complete the Medical Device User Fee Cover Sheet online at the FDA’s MDUFA cover sheet page. Register with your Employer Identification Number for U.S. firms or DUNS number for foreign firms, then answer the questions about the type of application you are filing. When you click “Submit,” the system generates a unique payment identification number beginning with the letters “MD.” That number links your payment to your submission, and you should include it when you pay.5U.S. Food and Drug Administration. MDUFA Cover Sheets

As of October 1, 2025, the FDA no longer accepts checks. The two accepted methods are online payment by electronic check (ACH/eCheck) through the FDA’s user fee payment portal, or bank wire transfer. If you wire, add your bank’s wire fee to the total so the FDA receives the full amount, and include your MD-prefixed identification number with the transfer.

Upload Through the CDRH Portal

The primary submission channel is the CDRH Portal, an online gateway where any registered user can upload premarket submissions directly to the FDA. The portal also lets you track the status of your submission after upload. Include a copy of the completed MDUFA cover sheet as the first page of your submission package.3Food and Drug Administration. Send and Track Medical Device Premarket Submissions Online: CDRH Portal

If your finished eSTAR exceeds the portal’s 4 GB total or 1 GB per-attachment limits, or you cannot use the portal for another reason, you can mail the electronic version on physical media to the CDRH Document Control Center:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center (DCC) – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

What Happens After You Hit Send

The FDA’s first step is a technical screening that verifies the PDF’s integrity, confirms attachment buttons contain relevant documents, and checks that your drop-down responses are accurate. Because eSTAR automates content checks that previously occurred during the Refuse to Accept review, the FDA does not conduct a separate RTA review for eSTAR submissions. Within 15 days of receipt, the FDA sends an electronic notification of the acceptance review result, identifying the lead reviewer assigned to your 510(k).6U.S. Food and Drug Administration. 510(k) Submission Process

Mistakes That Trigger Holds

The validation logic catches blank fields and missing attachments, but it cannot catch everything. The FDA has flagged three issues that most often lead to early holds during technical screening:2FDA. eSTAR Program

  • Irrelevant attachments, where a document is uploaded to a button but does not actually address the question being asked.
  • Inaccurate drop-down responses. Selecting the wrong option in a branching menu causes the form to skip subsequent questions, so the FDA receives an incomplete picture of your device. The agency specifically warns this is a common source of early holds.
  • Submitting while the status bar still reads “eSTAR Incomplete.” The FDA will place the submission on hold and email you a screenshot of the unfinished sections.

Once a submission is placed on a technical screening hold, it stays on hold for up to 180 days or until you submit a complete replacement eSTAR, whichever comes first. That 180-day window is a deadline, not a grace period. If you do not respond, the submission lapses.