Frequently Asked Questions

eSTAR stands for “Electronic Submission Template And Resource”

eSTAR is designed and structured in a similar format as FDA’s 510(k) reviewers’ Smart template, and includes a collection of questions, text, logic, and prompts that guide a user through preparation of a 510(k) submission. In addition, the functionality and content of the eSTAR application are embedded within a PDF which will allow industry more flexibility when developing, viewing, and editing a 510(k).
See the complete comparison between eSTAR and eSubmitter

1. Download either the Non-In Vitro Diagnostic eSTAR PDF or the In Vitro Diagnostic eSTAR PDF template. Be sure to save the document on your computer by right clicking the link, (or pressing “control” + clicking on a Mac) and choosing Save Link As/Download Linked File, before you open it in Adobe Acrobat Pro and begin entering in data.
   Note: This template is only used for constructing, not submitting, your 510(k) submission. The directions at the end of the template provide instructions on how to submit.
2. Read, understand, and follow the directions in the Introduction, Key, FAQ, and Version History sections of the eSTAR PDF template.
3. Fill in the template accordingly.

If you are participating in the voluntary eSTAR pilot program, your submission should include:

• The eSTAR PDF with embedded attachments on a CD, DVD, or USB Drive (SD cards are not accepted).
• A printed cover letter to the Document Control Center (DCC). For the current mailing address for CDRH’s Document Control Center, see eCopy Program for Medical Device Submissions.

For example, an acceptable submission package would consist of a printed cover letter accompanying a USB drive containing the eSTAR PDF.

Indicate the “Application Sub-Type” is “Additional Information” in the first section of the eSTAR “Application/Submission Type.” After you indicate this, an additional section will appear to provide responses to requests for additional information.

510(k)s submitted as part of the voluntary eSTAR pilot program are subject to user fees. For the current User Fee amounts, please see MDUFA User Fees.

After the FDA receives an eSTAR-prepared 510(k) within the eSTAR Pilot Program, the FDA does not intend to conduct the RTA process. The remainder of the review will be conducted according to the FDA guidance “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” and the procedures identified in 21 CFR 807 subpart E.

• Have questions regarding the pilot or eSTAR content
• Find any malfunctions or errors in the eSTAR template
• Would like to provide feedback about the use of eSTAR. You can also comment on the docket in the Federal Register