Question 1

What is eSTAR authoring software?

Accepted Answer

eSTAR authoring software is a specialized workspace for preparing FDA eSTAR (electronic Submission Template And Resource) submissions. eSTAR is an interactive PDF form that FDA CDRH uses for 510(k) and, increasingly, De Novo submissions. Authoring software structures the content that will populate the eSTAR form (predicate comparisons, performance testing, labeling, software documentation, etc.), coordinates review across RA, QA, and engineering, and exports a validated eSTAR that uploads cleanly through CDRH Portal. Without dedicated tooling, teams work inside the raw eSTAR PDF which is error-prone and difficult to collaborate on.

Question 2

Does Assyro replace the FDA eSTAR template?

Accepted Answer

No. FDA issues the eSTAR template and updates it periodically. Every 510(k) and De Novo submission must be filed using the current FDA eSTAR. Assyro is the authoring layer that sits around the eSTAR: teams build content in a structured collaborative environment, and Assyro populates the FDA eSTAR form with the final content when the team is ready to submit. The PDF that goes to FDA is the official eSTAR, not an Assyro document.

Question 3

Which device pathways does eSTAR Authoring support?

Accepted Answer

eSTAR supports FDA 510(k) submissions (Traditional, Abbreviated, and Special) and De Novo classification requests. FDA mandated eSTAR for all 510(k) submissions as of October 1, 2023, and extended eSTAR to De Novo submissions in 2024. Assyro covers all three 510(k) variants and De Novo authoring. Premarket Approval (PMA) submissions do not use eSTAR and follow a different technical pathway.

Question 4

How does Assyro handle eSTAR's 90+ conditional attachments?

Accepted Answer

The eSTAR attachment list is conditional on device type, product code, technological characteristics, and the specific claims in the submission. A software device needs software documentation; a combination device needs a human factors report; a contacting-tissue device needs biocompatibility data. Assyro maps the required attachment set based on the device's classification and technological profile, surfaces the required list up front, and tracks closure on each one with an assigned owner. No more discovering at T-7 that the 24-month stability data was never requested.

Question 5

Can engineering, QA, and RA work in the eSTAR at the same time?

Accepted Answer

Yes. Role-based section access lets engineering fill in verification and validation sections, QA handle risk management and labeling, RA own predicate logic and regulatory correspondence, all concurrently. Changes propagate into the eSTAR form state without overwrite conflicts. In Word + SharePoint workflows, the eSTAR becomes a serialized bottleneck where one person at a time can safely edit. Assyro removes that bottleneck.

Question 6

How long does a 510(k) take to author in Assyro?

Accepted Answer

For a device with existing predicate analysis, completed verification testing, and finalized labeling, the eSTAR authoring itself typically takes 3-5 working days of focused effort in Assyro, versus 2-4 weeks in a traditional Word-plus-SharePoint workflow. The big time savings are in review coordination (not the writing itself), attachment management, and the elimination of last-minute cross-reference cleanup. Total 510(k) elapsed time also depends on upstream work (testing, labeling) that Assyro doesn't accelerate directly.

Question 7

What happens when FDA updates the eSTAR template?

Accepted Answer

FDA publishes new eSTAR versions periodically (most recently September 2025). When a new version releases, submissions in flight can continue with the version they started with through a cutover window; new submissions must use the current version. Assyro tracks FDA eSTAR versioning and migrates in-progress submissions to the current template when the team is ready, preserving all the content already drafted. Teams don't have to rebuild a submission because of an eSTAR version change.

Question 8

Does Assyro support Pre-Submission meetings (Q-Sub)?

Accepted Answer

Yes, as an adjacent workflow. Pre-Submissions (Q-Subs) are not eSTAR submissions but often drive the content strategy that ends up in the 510(k). Assyro supports Q-Sub briefing document authoring, FDA feedback capture, and the linkage from Q-Sub outcomes into 510(k) eSTAR content (for example, when FDA agrees to a specific performance testing approach in the Q-Sub and that testing result needs to be referenced in the eSTAR). Keeping Q-Sub and 510(k) in the same platform preserves the traceable decision chain that FDA reviewers look for.

eSTAR Authoring Software

How eSTAR Authoring Fits the Submission Workflow

Assemble eSTAR Packages Without the PDF Form Dance

Coordinate Predicate, Testing, and Labeling in One Place

Flag Missing Attachments Before the Deadline

Skip the Last-Week Scramble Between RA, QA, and Engineering

Controls and Traceability for eSTAR Authoring

Keep eSTAR Authoring Audit-Ready

Scale Across Programs Without Adding Complexity

Questions About eSTAR Authoring

See eSTAR Authoring in a Live Submission Workflow.