--- title: "eSTAR, Definition | MedTech Terms" description: "FDA's interactive PDF template for preparing and submitting 510(k) and De Novo submissions. Plain-English Regulatory definition for MedTech teams, with examples" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/estar#term", "name": "eSTAR", "description": "eSTAR is a guided, structured submission template that performs automated content checks. 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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." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. eSTAR [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets) # eSTAR FDA's interactive PDF template for preparing and submitting 510(k) and De Novo submissions. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last 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](/terms/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)](/terms/510k)s, eSTAR is mandatory, as outlined in FDA guidance documents. It is also an accepted submission method for [De Novo](/terms/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](/terms/de-novo), and FDA is expanding eSTAR to [PMA](/terms/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](/terms/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](/terms/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 Is eSTAR mandatory? 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](/terms/de-novo). [PMA](/terms/pma) support is being rolled out in phases. Does eSTAR replace RTA? How do I download the eSTAR template? Does eSTAR include cybersecurity content? ## Cross-references ### Used by Things that build on this term. - [ 510(k) Premarket Notification(510(k)) ](/terms/510k) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory De Novo Classification Request(De Novo) Pathway to classify novel low- to moderate-risk devices that lack a predicate. ](/terms/de-novo)[ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma)[ Regulatory Refuse to Accept(RTA) FDA administrative decision that a submission is incomplete and won't be substantively reviewed. ](/terms/rta) ### More in Regulatory · Same category [ Regulatory 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. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k)[ Regulatory Accreditation Scheme for Conformity Assessment(ASCA) FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny. ](/terms/asca) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 2 verified 1 unchecked · last checked 2026-06-20 FDA· 2 RAPS· 1 1. [1 FDA eSTAR Program Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program) 2. [2 eSTAR for Medical Device Submissions Unchecked FDA · fda.gov ](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/electronic-submission-template-medical-device-510k-submissions) 3. [3 RAPS Regulatory Focus Verified RAPS · raps.org ](https://www.raps.org/news-and-articles/news-articles) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=estar) Learn in 60 seconds Card Lesson Quiz 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. Related terms - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [De Novo Classification Request(De Novo) ](/terms/de-novo) - [Premarket Approval(PMA) ](/terms/pma) - [Refuse to Accept(RTA) ](/terms/rta) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) - [Section 524B of the FD&C Act(524B) ](/terms/section-524b) You may also need Auto-suggested from Regulatory and shared keywords. - [513(g) Request for Information(513(g)) ](/terms/513g) - [Device Master File(MAF) ](/terms/device-master-file) - [Breakthrough Device Designation(BDD) ](/terms/breakthrough-device) - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) - [Abbreviated 510(k) ](/terms/abbreviated-510k) - [AI Act Transparency Obligations ](/terms/ai-act-transparency-obligations) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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