What is FDA eSTAR? The Mandatory Electronic Submission Template Explained

eSTAR (Electronic Submission Template and Resource) is the FDA’s standardized, interactive PDF template for premarket device submissions. As of October 1, 2023, eSTAR is mandatory for all 510 k submissions. As of October 1, 2025, it is mandatory for de novo classification requests. PMA eSTAR templates exist for voluntary use but are not yet required.

If your team is preparing a medical device submission for the US market, eSTAR is the required format. This guide covers what it is, who must use it, which submission types are affected, and where submissions run into trouble.

What Is FDA eSTAR And What Does It Stand For?

eSTAR stands for Electronic Submission Template and Resource. It is FDA CDRH’s interactive PDF template for medical device premarket submissions.

A quick note for readers who arrived here searching for a different topic: the word “eSTAR” is also the Spanish verb meaning “to be,” referring to temporary states. In Spanish, both ser and eSTAR translate to “to be” in English but are used differently. Ser describes permanent traits while eSTAR describes temporary states. eSTAR describes emotions and temporary conditions, health and physical states, and the current physical state of objects or people. eSTAR also describes conditions that can change, actions in progress with a gerund, and location regardless of permanence. eSTAR describes the immediate taste or condition of food being consumed. You use ser for the location of events and eSTAR for the location of people and objects.

Temporary personality uses eSTAR while ser is for typical personality, and some adjectives change meaning completely between ser and eSTAR. A helpful acronym for remembering when to use eSTAR is PLACE, which stands for Position, Location, Action, Condition, Emotion. This article, though, is about the FDA regulatory template. Read on for everything you need to know about the fda eSTAR program.

The eSTAR template is an interactive PDF form, not a web portal or standalone software. It runs in Adobe Acrobat Pro or Adobe Acrobat Reader and uses dynamic fields, dropdown menus, hyperlinks, and built-in validation checks. eSTAR templates include built-in error-checking features that flag missing or incorrect information before submission.

The main submission types supported include:

• 510 k submissions (Traditional, Special, Abbreviated)
• De novo requests
• Certain pma submissions and investigational device exemptions
• Early submission requests eSTAR (PreSTAR for q submissions and 513(g) requests)

The template is designed to mirror FDA reviewer workflows. It pre-loads regulatory logic and forms like the Indications for Use statement, 510(k) cover sheet, and declaration of conformity. The eSTAR program began as a pilot in February 2020 and has expanded steadily since.

Completed eSTAR submission files are transmitted through the CDRH Customer Collaboration Portal for CDRH-regulated devices and via ESG for CBER submissions.

Is eSTAR Mandatory? Key Dates For 510(k), De Novo, And Other Submissions

Since October 1, 2023, all non-exempt 510 k submissions must use the eSTAR format. Since October 1, 2025, all non-exempt de novo requests must also use eSTAR.

What does “mandatory” mean in practice? CDRH will not accept new 510(k) or De Novo medical device submissions that do not use the appropriate current eSTAR template unless a waiver or exemption is granted under the electronic submission guidance. If FDA receives a submission without eSTAR, or with an eSTAR in “INCOMPLETE” status, the submission will not be accepted into technical screening.

Before October 2023, eSTAR was voluntary for 510 k submissions. Before October 2025, eSTAR was voluntary for de novo submissions. Many sponsors relied on legacy eCopy formats and static PDFs. That option no longer exists for these submission types.

Limited circumstances may qualify for waivers. The final guidance documents for both 510(k) and De Novo include sections on exemptions. Qualifying for and documenting a waiver request is itself a process that warrants careful attention. Exemptions are narrow and are not a default fallback.

PMA and IDE eSTAR templates are available for voluntary use. As of July 2026, FDA has not issued a final mandatory date for these submission types, though draft policies for broader eSTAR use in q submissions exist.

If your company is preparing a 510(k) or De Novo today, you must use eSTAR. No workaround exists.

Which Submission Types Require eSTAR Today?

The table below summarizes which submission types require eSTAR, which support voluntary use, and the applicable dates. eSTAR simplifies premarket submissions for medical devices and works across various medical device categories.

Medical devices are classified into Class I, II, and III. Class I devices are low-risk and often exempt from 510(k). Class II devices require a 510(k) submission for substantial equivalence. Class III devices undergo the most rigorous premarket approval (PMA) process. eSTAR applies across all device classifications, though the submission pathway determines which template you use.

What this means for you depends on where your company sits:

• Startups filing a first 510(k): Your submission must use eSTAR. Factor template learning time into your project plan from day one.
• Established manufacturers using De Novo for novel devices: The de novo classification process now requires eSTAR. Your regulatory team needs to be current with both the template and the content expectations it imposes.
• International firms entering the US market: The electronic submission requirements apply regardless of where your company is headquartered. eSTAR is the submission format for 510 k de novo pathways, period.

Companies planning 510(k) or De Novo regulatory submissions in FY 2026 should assume eSTAR will be required and factor template requirements into their project timeline from day one.

Current eSTAR And PreSTAR Versions

FDA updates eSTAR and PreSTAR regularly. Sponsors must use the current versions posted on the fda website at the time they start a new submission. Using an outdated version is itself a source of deficiencies.

On June 1, 2026, FDA released eSTAR version 7.0 and PreSTAR Version 3.0. The enforcement date for new submissions started after the transition period is August 3, 2026.

Key changes in eSTAR 7.0 include:

• Integration of updated Human Factors guidance within performance testing sections
• Improved ordering of consensus standards
• Updated PMA facility information fields
• General bug fixes

The current eSTAR template version prior to this update was 6.1 for both nIVD and IVD devices. The previous version remains acceptable only for follow-up responses to already-submitted files. New dossiers must use the active versions.

PreSTAR 3.0 expanded coverage for early submission requests, including new Q-Sub types such as submission issue requests, study risk determinations, PMA day 100 meetings, and accessory classification requests.

The transition between versions requires attention. Version mismatches are a known source of AI Requests, and the version history on page one of each template should be checked against current online listings before significant drafting work begins.

How eSTAR Works Inside: Structure, Logic, And Key Sections

eSTAR is divided into sections that mirror FDA’s internal review structure, with required questions, conditional logic, and document attachment slots. The structure is more demanding than it first appears.

The main sections include:

• Administrative information
• Device description
• Indications for use
• Classification and predicate selection (for 510(k))
• Technological characteristics
• Performance testing
• Labeling
• Sterilization
• Biocompatibility
• Cybersecurity

eSTAR uses color coding and a status message system. A status of “eSTAR complete” means all required questions have been answered within the form. A status of “eSTAR INCOMPLETE” means required fields remain. But “COMPLETE” status reflects form completion, not scientific adequacy. This is a distinction that catches many first-time submitters off guard.

Built-in blue information banners and question mark icons expand to reveal regulatory expectations, examples of acceptable content, and links to relevant guidance documents. eSTAR improves submission accuracy with automated error-checking through these embedded tools.

The template consolidates previously separate forms, including the Indications for Use form, 510(k) cover sheet, and declaration of conformity. Responses must be consistent across all sections to pass FDA technical screening. Inconsistencies across these consolidated fields are among the most common deficiency triggers in the fda review process.

Information Required In An eSTAR Submission

A complete submission in the eSTAR format covers a wide range of content categories. The goal here is to give you a sense of scope and complexity, not to serve as a content checklist. A comprehensive medical device submission through eSTAR requires high quality data across every category.

Core content areas include:

• Cover letter text
• Administrative information
• Device description
• Intended use and indications for use
• Technological characteristics
• Risk analysis
• Substantial equivalence rationale (for 510(k)) or benefit-risk rationale (for De Novo)

Technical evidence types within the submission data include:

• Bench testing and performance testing
• Biocompatibility
• Electromagnetic compatibility (EMC) and electrical safety
• Software and cybersecurity documentation
• Usability and human factors data
• Clinical data (when required)

Labeling content should cover instructions for use, packaging labels, promotional claims, and any patient-facing information. All labeling documents must be uploaded into the appropriate attachment slots within the eSTAR pdf template.

For AI-enabled devices, additional content includes software description, algorithm training and validation summaries, and references to current fda guidance for machine learning and real world evidence. These fields require particular care and are an area where submissions frequently fall short.

Electronic Submission Basics: From Template To CDRH Portal

The high-level electronic submission workflow sounds simple: download the correct eSTAR template, complete all sections in Adobe Acrobat, validate, then upload through the CDRH portal. The submission process sounds linear. In practice, each step has dependencies and failure points that compound.

The CDRH portal is FDA’s Customer Collaboration Portal for CDRH-led premarket submissions. It supports 510(k), De Novo, PMA, IDE, and Small Business Determination Requests. CBER eSTAR submissions use the Electronic Submission Gateway (ESG), with separate onboarding and technical requirements published on the fda website.

No physical cover letter is needed once the eSTAR package is uploaded through the portal. A cover letter section still lives inside the template itself and must be completed there.

eSTAR submissions must be complete to avoid a 180-day hold. Submissions must reach “eSTAR COMPLETE” status before upload. Incomplete templates can be placed on hold during technical screening, a delay that can cost months before substantive review even begins. eSTAR enhances transparency in the submission process because both sponsor and FDA can track status at every stage.

Submitting Through The CDRH Portal

The cdrh portal submission process involves account creation through Okta-based identity verification, followed by selection of the correct submission type during upload. The process requires setup, and understanding what is involved matters before you begin.

The attachment framework requires planning:

• The main eSTAR PDF plus associated submission files are subject to a 4 GB total portal upload limit
• Individual PDF attachments are limited to 1 GB each
• These constraints require deliberate file planning, particularly for data-heavy submissions

After upload, the Portal provides a tracking dashboard showing receipt date, technical screening status, AI Requests, and final decision messages. The official correspondent for the submission and any designated delegates can view progress and receive notifications.

Submissions exceeding portal file limits must be mailed to the cdrh document control center. This is an edge case, but one that requires specific handling. It is not a matter of dropping a USB drive in the mail.

eSTAR User Fees, De Novo Fees, And Annual Establishment Fee

There is no separate “eSTAR fee.” Standard FDA user fees still apply to 510(k), De Novo, and pma submissions regardless of submission format. Fees must be paid in full before FDA begins substantive review.

Key fee considerations:

• 510(k) user fees vary by fiscal year and small business status
• De Novo user fees follow their own schedule
• PMA submissions typically require 180 days for review and carry their own fee structure
• The MDUFA annual establishment registration fee is a separate cost for every manufacturing establishment. The FY 2025 value was $9,280, with no small business discounts for this fee

User fee payment confirmation details must be captured in the administrative section of eSTAR. Mismatches between payment and application can delay acceptance into substantive review.

A practical example: a small company submitting one Traditional 510(k) in FY 2026 would pay the 510(k) user fee plus the annual establishment fee after clearance, while eSTAR itself remains a free FDA-provided template.

Preparing To Use eSTAR: Practical Setup Steps

Submission preparation for eSTAR takes more time than most teams expect. This section gives you a sense of what is involved, not a procedural checklist.

Software compatibility matters. eSTAR requires the latest version of adobe acrobat pro or Adobe Acrobat Reader. Browser-based PDF viewers will not render the interactive pdf form correctly. This is a common source of early-stage frustration.

Submission type selection determines which template to download. Traditional 510(k), Special 510(k), De Novo, PMA pilot, or early submission requests via PreSTAR each have distinct templates. Choosing the wrong one creates rework.

Internal document organization and version control across performance reports, labeling, and risk files must align with what is attached into eSTAR. Misalignment between internal records and eSTAR content is a recurring problem that affects how fda reviewers evaluate the complete submission.

First-time eSTAR submissions consistently take longer than teams expect. Allocating adequate time is one of the most important preparation decisions. Underestimating it is one of the most common ones.

File Sizes, Attachments, And Technical Limits

The CDRH Portal imposes strict limits: total submission size up to 4 GB and individual PDF attachments up to 1 GB. For image-heavy or video-rich performance reports across various medical devices, these limits require deliberate file planning.

eSTAR accepts multiple attachment types, including PDF, certain image formats, and some media. It will block unsupported formats and prevent validation. Not every file format a team routinely uses will be accepted.

Managing large data sets within these limits requires decisions about file consolidation and structure. These decisions have downstream implications for how fda reviewers access and reference specific submission data.

Oversized submissions that cannot be compressed within portal limits must be mailed to the CDRH Document Control Center. This is a documented option, not a workaround, and requires following specific FDA procedures.

File naming and structure inside the eSTAR package affect how internal bookmarks and reviewer references function. Errors here are invisible until they cause problems during FDA review.

Common eSTAR Errors That Trigger Additional Information (AI) Requests

A significant portion of 510 k submissions and de novo submissions receive AI Requests. Many of those requests result from preventable eSTAR-related issues rather than scientific deficiencies. These are common submission errors that add months to review timelines.

“eSTAR COMPLETE” status does not mean the submission is ready for substantive review. Technical completeness and scientific adequacy are two separate bars. Passing the first does not guarantee clearing the second. eSTAR submissions are not expected to undergo rta review in the traditional sense, but technical screening still catches incomplete or malformed content.

AI Requests pause FDA’s review timeline and give sponsors 180 calendar days to respond. The FDA aims to review standard 510(k) submissions within 90 days, but that clock stops when an AI Request is issued. Delays from preventable errors can push market entry back by months and create downstream pressure on funding, partnerships, and launch plans.

The error categories below reflect what experienced reviewers see most frequently across submission types. The specific combination of errors in any given submission is rarely obvious until an experienced reviewer looks at the file as a whole.

Inconsistency Between Device Description, Indications, And Technology Sections

eSTAR separates device description, indications for use, and technological characteristics into different parts of the template. These sections are frequently drafted by different team members at different times.

The consequence: even minor wording differences across these fields trigger AI Requests. “Monitoring” versus “diagnosing.” Adult use in one section and pediatric mention in another. FDA reviewers interpret these as substantive inconsistencies requiring clarification, not as typos.

This error is among the most common AI Request triggers, and it is one of the most avoidable. The challenge is that it requires comparing sections that live in different parts of a long, complex interactive pdf. Cross-section consistency work requires a structured approach. Teams who attempt it informally at the end of a drafting process rarely catch everything.

Broken Bookmarks, Hyperlinks, And Cross-References

eSTAR and Adobe Acrobat bookmarks allow fda reviewers to move directly from summary sections to supporting data, test reports, and appendices. When these links break, reviewers lose the ability to verify claims efficiently.

Broken hyperlinks and missing bookmarks are a common source of AI Requests asking sponsors to clarify where specific data can be found. This adds response burden for what is fundamentally a navigation problem, not a scientific one.

PDF assembly in eSTAR involves multiple submission files, attachment slots, and internal cross-references that interact in ways not always visible in the authoring environment. Problems often appear only when the file is reviewed on a different system. A thorough pre-submission technical review of the final compiled PDF is not optional.

Weak Or Incomplete Substantial Equivalence And Benefit-Risk Rationale

For 510 k submissions, eSTAR requires an explicit predicate device selection and a structured substantial equivalence comparison covering intended use, technological characteristics, and performance outcomes.

Common weaknesses include:

• Naming a predicate without a comparative analysis
• Omitting discussion of identified differences
• Failing to tie performance data back to specific risks and device characteristics

Each of these patterns triggers AI Requests and can lead to NSE (Not Substantially Equivalent) determinations.

For de novo requests, eSTAR must capture benefit-risk reasoning and risk management summaries at a level of specificity that goes well beyond high-level statements about innovation or unmet need.

Substantial equivalence and benefit-risk arguments are the intellectual core of a submission. Weak rationale here is not a formatting problem. It is a strategy problem that affects whether clearance or fda approval is achievable at all.

Improperly Embedded Attachments And Misplaced Files

eSTAR has specific attachment slots for each document category: bench performance, biocompatibility, sterilization validation, software documentation, clinical data, and others.

Placing a document in the wrong slot, or referencing an attachment that was never uploaded, creates a technical deficiency that FDA flags during screening. The submission goes on hold before substantive review begins. Missing information in the wrong slot is treated the same as missing information entirely.

This category of error is entirely preventable. Preventing it requires a disciplined attachment review process that accounts for how each slot is labeled and what FDA expects in each location. The attachment organization in a well-prepared eSTAR submission reflects decisions made throughout the drafting process, not corrections applied at the end.

Incomplete Required Fields And Placeholder Text

eSTAR’s built-in validation catches some missing data but not all. Fields marked “eSTAR COMPLETE” may still contain placeholder text, minimal narrative, or “N/A” responses that fda reviewers do not accept as adequate.

Submitters sometimes treat reaching “COMPLETE” status as the finish line. It is not. Reviewers evaluate the quality and specificity of the content inside each field, not just whether something was entered.

Key risk areas for thin or inadequate field content include cybersecurity, software description, human factors, and risk management. Data suggests less than 4% of human factors submissions are accepted without an AI Request. What constitutes sufficient depth varies by device type, risk classification, and predicate strategy. A generic response to any of these fields is rarely adequate for effective medical devices seeking clearance.

What Happens When FDA Issues An Additional Information (AI) Request?

AI Requests are formal letters from FDA asking sponsors to clarify or expand information submitted in eSTAR. They are typically issued after the substantive review phase begins.

The review clock stops on the date the AI Request is issued. It remains paused until FDA receives a complete response or until the 180-day response window expires. If no complete response arrives within that window, FDA may consider the submission withdrawn.

AI Requests can include both scientific questions and technical eSTAR corrections. Miscategorized test reports, inconsistent statements, and missing attachments may all appear in a single request alongside questions about clinical data or performance testing methodology.

The sponsor receives the letter, assesses scope, and must produce a coordinated response that addresses each item completely. Incomplete or piecemeal responses do not reSTARt the review clock effectively and can extend the delay further.

A well-organized response is more than reassembly of existing content. It requires demonstrating to FDA that the underlying issue has been understood and fully resolved.

When the original eSTAR was weak, that may mean substantive rework. eSTAR reduces review times for medical device submissions, but only when the initial submission is complete and well-prepared. eSTAR improves submission quality and reduces review timelines when used correctly from the start.

How To Reduce AI Request Risk Before Submission

AI Request risk reduction is a structured pre-submission discipline, not a last-minute proofreading exercise. By the time a team is “checking” the file, many of the decisions that determine submission quality have already been made.

The most consequential issues cannot be caught by reading the eSTAR in isolation. Inconsistent device descriptions, weak predicate arguments, and inadequate performance justifications require evaluating the submission as FDA will read it: as a complete package, not section by section.

Version verification matters. Using an outdated eSTAR or PreSTAR version is a source of deficiencies that has nothing to do with the submission’s scientific strength.

Pre-Submission (Q-Sub) meetings hold significant value for higher-risk devices, novel technologies, or borderline classification cases. A pre-submission meeting before eSTAR content is finalized can prevent fundamental strategy errors that no amount of technical review will fix after the fact.

The gap between an internal review and an expert review is not about checking the same items more carefully. It is about knowing which items to look for in the first place. Pattern recognition that comes from experience across submission types, device categories, and FDA feedback cycles is what separates the two.

Early Submission Requests Using PreSTAR

Early submission requests such as q submissions, pre submissions, and certain IDE interactions now use the PreSTAR interactive pdf template. PreSTAR is related to eSTAR but targeted at premarket communication rather than marketing authorization.

PreSTAR supports multiple request types:

• Pre-submission meetings
• Submission issue requests
• Informational meetings
• Study risk determinations
• Accessory classification requests

As of 2026, PreSTAR is voluntary for most early interaction types. Separate draft guidance proposes a future transition where certain Q-Subs will move to required electronic templates after a defined phase-in period.

Using PreSTAR early in development helps teams understand the structure and expectations that will appear in their eventual marketing submission. It is useful preparation even when it is not yet required. Teams should track PreSTAR version changes (such as the June 1, 2026 release of PreSTAR 3.0) and FDA announcements about when early submission requests will shift from voluntary to required. Version discipline matters here for the same reasons it matters in eSTAR.

Electronic Submission Template Policy And Exemptions

The broader FDA policy framework behind eSTAR is defined in guidance documents on electronic submissions for medical device 510 k submissions and de novo requests.

These guidance documents define which submission types are subject to electronic submission requirements, how eSTAR fulfills those requirements, and under what conditions exemptions or waivers may be granted. The relevant guidance document for 510(k) is “Electronic Submission Template for Medical Device 510(k) Submissions,” with a De Novo counterpart.

Common exemption categories exist but are narrow. The final guidance defines them, and sponsors should consult the current version directly rather than relying on summaries. What qualified for an exemption at launch may not qualify today.

Even when exemptions exist, FDA strongly encourages use of eSTAR or PreSTAR when technically feasible. The exemption process is not a shortcut. It adds administrative steps and does not guarantee a smoother approval process. FDA’s digital transformation of regulatory processes continues to move toward electronic-only submission.

eSTAR, QMSR, and Quality System Documentation

On February 2, 2026, FDA’s Quality Management System Regulation (QMSR) replaced the previous Quality System Regulation (QSR), aligning more closely with ISO 13485:2016.

Current eSTAR versions incorporate QMSR concepts in sections covering design controls, risk management, production controls, and post-market surveillance processes. Inspectors cross-check references in eSTAR to quality system documentation, including SOPs, quality certificates, and design history files, against actual practices during FDA facility visits. Claims made in eSTAR have real inspection implications.

FDA’s compliance program manual CP 7382.850 replaced QSIT as the inspection reference. Inspectors may reference eSTAR content when evaluating facility compliance.

Regulatory and quality teams need to coordinate before eSTAR is finalized. Descriptions of design controls, CAPA, and complaint handling inside eSTAR must reflect current, documented procedures. Medical device manufacturers must treat these sections as statements of record, not aspirational descriptions.

Real World Evidence (RWE), Clinical Data, And eSTAR

Recent eSTAR versions include fields aligned with FDA’s December 2025 guidance on Real World Evidence for devices. This is part of FDA’s broader effort to support high quality medical devices through evidence-based regulatory decisions.

eSTAR prompts sponsors to indicate whether RWE is used, what data sources were leveraged (registries, electronic health records, claims data), and how data quality and relevance were assessed. Clinical data from RWE must be presented with the same rigor as traditional clinical evidence.

FDA reviewers apply the updated RWE standards and will scrutinize how data were collected, curated, and analyzed. A high-level statement that RWE was used is not sufficient. The evidentiary standard is specific and demanding.

Sponsors who plan to use RWE should raise their approach during a Pre-Submission meeting before eSTAR is finalized. Submitting without prior FDA alignment on an RWE strategy is a significant risk. This area is evolving, and the expectations reflected in eSTAR fields will continue to develop. Teams unfamiliar with current FDA thinking on RWE for devices should seek guidance before drafting these sections.

Benefits Of Using eSTAR For Sponsors And FDA

eSTAR delivers tangible benefits when used well:

• Better structure and a structured format reduce variation between submissions
• Fewer missing elements, with built-in validation reducing common submission errors
• Complete submissions are more likely to pass initial technical screening, moving directly into substantive review
• Standardized fields make it easier for fda reviewers to locate key data, compare devices, and apply consistent review tools
• eSTAR submissions are not expected to undergo rta review in the traditional sense, removing a friction point in the approval process

eSTAR reduces review times for medical device submissions and improves communication between sponsors and reviewers. Sponsors who invest in eSTAR proficiency early often find subsequent submissions easier to prepare across different product lines and pathways. The learning curve is real, but it compounds positively over time.

eSTAR is a long-term shift in how FDA interactions are structured, not a one-time formatting requirement. The teams that treat it as infrastructure rather than paperwork are the ones that build durable submission competency. eSTAR streamlines the submission process for medical devices across all device classifications, including vitro diagnostic devices.

Challenges And Limitations With eSTAR

Common user challenges include:

• Learning curve: The template is more complex than a standard PDF form
• Software compatibility: eSTAR does not render correctly in non-Adobe viewers; dynamic fields may malfunction
• File size limits: 4 GB total and 1 GB per attachment create constraints for data-heavy submissions
• Template rigidity: Complex or unusual device types may not fit neatly into the existing structure

Complex products like imaging systems, diagnostics with multiple modes, and combination products may push against file size and organizational limits in ways that require deliberate structural decisions.

FDA version updates require teams to review and adjust internal processes and documentation templates. Older checklists or internal guides may not match fields or expectations in versions like 7.0. Assuming continuity between the previous version and the current one is a risk.

eSTAR rewards experience. Teams who have been through the process before make different decisions about file structure, narrative depth, attachment organization, and cross-section consistency than teams working through it for the first time.

Working With An eSTAR Consultant Or Internal Specialist

Experienced eSTAR support, whether external consultants or in-house specialists who have prepared multiple submissions, reduces AI Request risk. This is particularly true for first-time submitters and novel device types.

What experienced support looks like in practice goes beyond template formatting and attachment organization. It includes strategic decisions about predicate selection, substantial equivalence framing, and benefit-risk positioning. These decisions shape whether the submission succeeds, not just whether it looks complete.

The cost decision is clear: the cost of a well-prepared submission is predictable. The cost of an AI Request, in timeline, resources, and market opportunity, often is not.

The situations where outside expertise adds the most value include:

• First 510(k) or De Novo submissions
• Devices with complex technology or limited predicate options
• Submissions following a prior NSE or AI Request
• Teams without recent submission experience

IMDS works with medical device manufacturers at every stage, from pre-submission strategy through eSTAR preparation and AI Request response. If your team is preparing a 510(k), De Novo, or early submission request and wants to reduce the risk of a hold, contact IMDS to discuss your submission.