eSTAR
FDA's interactive PDF template for preparing and submitting 510(k) and De Novo submissions.
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. eSTAR is an interactive PDF template that guides submitters through each required section, with built-in logic that shows or hides questions based on device type and automated checks for missing content. It has been mandatory for most 510(k) submissions since October 1, 2023, and is also available for De Novo requests. Submissions are sent electronically through the CDRH Portal.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.
- •Using an outdated eSTAR template.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
Cross-references
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Pathway to classify novel low- to moderate-risk devices that lack a predicate.
FDA's most stringent device marketing application, required for high-risk Class III devices.
FDA administrative decision that a submission is incomplete and won't be substantively reviewed.
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· Same categoryTwo 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.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.
Where this term appears across MedTech Terms.
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Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1FDA eSTAR ProgramTier 2 VerifiedFDAfda.gov
- 2eSTAR for Medical Device SubmissionsTier 2 VerifiedFDAfda.gov
- 3RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
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