Does eSTAR replace RTA?

Effectively yes for 510(k). Because eSTAR performs automated completeness checks before submission, FDA does not conduct a separate RTA review of eSTAR-submitted 510(k)s. Substantive review begins on receipt.

How do I download the eSTAR template?

The current template is available on the FDA eSTAR Program page. Always download a fresh copy for each submission because FDA revises the template several times a year.

Does eSTAR include cybersecurity content?

Yes. Recent eSTAR versions include dedicated sections for cybersecurity documentation aligned with Section 524B and the 2023 premarket cybersecurity guidance: SBOM, threat model, vulnerability management plan, and security testing evidence.

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eSTAR

FDA's interactive PDF template for preparing and submitting 510(k) and De Novo submissions.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

eSTAR is a guided, structured submission template that performs automated content checks. It is mandatory for 510(k) submissions and supported for De Novo submissions to FDA's CDRH.

What the regulation says

The FDA introduced eSTAR (electronic Submission Template And Resource) as a standardized, interactive PDF template to streamline medical device submissions. For 510(k)s, eSTAR is mandatory, as outlined in FDA guidance documents. It is also an accepted submission method for De Novo requests to FDA’s Center for Devices and Radiological Health (CDRH).

What this means in practice

As of October 1, 2023, eSTAR is mandatory for all 510(k) submissions (except for dual and CBER-led submissions). It is voluntary but supported for De Novo, and FDA is expanding eSTAR to PMA in phases. eSTAR uses a guided PDF template (Adobe Acrobat) with automated content validation: mandatory fields, conditional logic, integrated FDA guidance links, and eCopy replacement. Using eSTAR bypasses the traditional RTA review for 510(k) because the template's automated checks perform the acceptance validation up front. Vendors increasingly build internal tools that map QMS records (design outputs, verification, validation, labeling, cybersecurity artifacts) directly to eSTAR sections.

Examples

A Class II 510(k) team completes an eSTAR template with embedded SBOM, threat model, and pen test PDFs in the cybersecurity section, then submits via the CDRH Customer Collaboration Portal.
A De Novo sponsor voluntarily uses eSTAR for the classification request to benefit from automated completeness checks and structured cybersecurity sections.

Common pitfalls

•Using an outdated eSTAR template. FDA updates eSTAR regularly; using a previous version causes submission rejection.
•Missing embedded attachments. eSTAR expects supporting documents to be attached inline; external references or missing PDFs fail validation.
•Ignoring the cybersecurity section for cyber devices. eSTAR has dedicated cybersecurity fields aligned with Section 524B; leaving them incomplete triggers deficiencies even without a formal RTA.
•Trying to submit eSTAR on non-Adobe PDF readers. eSTAR relies on Adobe-specific JavaScript; other readers break the template.

Frequently asked questions

Yes for 510(k) submissions since October 1, 2023, with limited exceptions (dual submissions, CBER-led). It is voluntary but strongly recommended for De Novo. PMA support is being rolled out in phases.

Cross-references

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510(k) Premarket Notification(510(k))

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510(k) Premarket Notification(510(k))

FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

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De Novo Classification Request(De Novo)

Pathway to classify novel low- to moderate-risk devices that lack a predicate.

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Premarket Approval(PMA)

FDA's most stringent device marketing application, required for high-risk Class III devices.

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Refuse to Accept(RTA)

FDA administrative decision that a submission is incomplete and won't be substantively reviewed.

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510(k) Summary vs 510(k) Statement

Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.

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513(g) Request for Information(513(g))

Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.

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Abbreviated 510(k)

510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.

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Accreditation Scheme for Conformity Assessment(ASCA)

FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.

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Category: Regulatory
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Updated: 5/5/2026

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Learn in 60 seconds

FDA's interactive PDF template for preparing and submitting 510(k) and De Novo submissions.

·As of October 1, 2023, eSTAR is mandatory for all 510(k) submissions (except for dual and CBER-led submissions).
·It is voluntary but supported for De Novo, and FDA is expanding eSTAR to PMA in phases.
·eSTAR uses a guided PDF template (Adobe Acrobat) with automated content validation: mandatory fields, conditional logic, integrated FDA guidance links, and eCopy replacement.

Remember this

Watch out: Using an outdated eSTAR template. FDA updates eSTAR regularly; using a previous version causes submission rejection.

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