FDA De Novo Database Teardown: Grants by Year, Panel, and Pathway (1997-2025)
A deep quantitative teardown of the FDA De Novo database. Analysis of annual grant trends, review timelines, advisory panel distributions, and the strategic cost-benefit of the pathway.
When a MedTech company develops a first-of-a-kind medical device, the regulatory pathway choice is the single most critical decision in the product lifecycle. If the device carries low-to-moderate risk but lacks a legally marketed predicate device in the United States, it is automatically classified as Class III (high risk) by default. Historically, this meant the sponsor was forced to submit a massive, expensive Premarket Approval (PMA) application.
To resolve this regulatory bottleneck, Congress established the De Novo classification pathway under Section 513(f)(2) of the Food, Drug, and Cosmetic (FD&C) Act. The De Novo process allows sponsors of novel, low-to-moderate-risk devices to petition the FDA to create a new product classification, bypassing the PMA requirement and establishing a brand-new Class I or Class II classification.
For novel device startups, the De Novo pathway represents the holy grail: it creates a new market category where you are the first entrant, and your granted De Novo becomes the legally recognized predicate device that all future competitors must reference in their 510(k) submissions.
But what is the reality of the De Novo pathway? How long does the FDA actually take to review these submissions? How much does it cost, how often do requests succeed, and how has the pathway evolved over its nearly 30-year history?
This article delivers a complete quantitative teardown of the official FDA De Novo classification database. Based on historical data, peer-reviewed studies of premarket authorizations, and current FY2025 user fee schedules, we analyze De Novo grants by year, review times, panel concentration, and the impact of recent regulatory shifts.
For a detailed look at the administrative process itself, see our FDA De Novo classification guide. For context on other FDA premarket pathways, check out our FDA 510(k) clearance trends over time analysis, our FDA PMA Class III high-risk approval landscape analysis, and our FDA Breakthrough Device designation guide.
1. De Novo Grants by Year: Historical Trends (1997–2025)
The De Novo pathway was created by the Food and Drug Administration Modernization Act (FDAMA) of 1997. In its early years, the pathway was rarely used. Under the original 1997 framework, a sponsor had to first submit a Traditional 510(k) application, wait for the FDA to issue a Not Substantially Equivalent (NSE) determination, and only then submit a De Novo request. This "510(k)-first" requirement added months of unnecessary work and cost.
This changed with the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, which introduced the Direct De Novo pathway. Sponsors could now submit a De Novo request directly without filing a 510(k) first, provided they could demonstrate that no predicate existed. The pathway’s maturity was further solidified by the FDA’s final De Novo rule in October 2021, which codified the administrative structure, formatting, and acceptance criteria.
The table below traces the history of FDA De Novo grants from 1997 through Q1 2025:
Table 1: FDA De Novo Classification Grants by Year (1997–2025)
| Era / Year | De Novo Grants | Key Legislative or Regulatory Milestone |
|---|---|---|
| 1997–2012 (Pre-Direct Era) | ~5–15 / yr | Requires 510(k) submission and NSE determination first |
| 2013 | 19 | Implementation of the "Direct De Novo" pathway under FDASIA |
| 2014 | 29 | FDA begins publishing detailed De Novo Decision Summaries |
| 2015 | 30 | Increase in digital health and software (SaMD) De Novo interest |
| 2016 | 33 | Launch of MDUFA IV negotiations focusing on premarket timelines |
| 2017 | 31 | FDA issues draft guidance on De Novo acceptance review |
| 2018 | 44 | Peak year of the decade, driven by digital health approvals |
| 2019 | 31 | Transition to electronic submission formats begins |
| 2020 | 21 | Pandemic response redirects CDRH resources to EUAs |
| 2021 | 29 | FDA publishes the final De Novo Classification Process Rule |
| 2022 | 38 | MDUFA V reauthorization establishes new 150-day review goals |
| 2023 | 42 | Mandatory eSTAR transition announced for premarket submissions |
| 2024 | 47 | Post-pandemic recovery peak; 47 grants, the highest annual total to date |
| 2025 (Projected) | ~25–30 | Q1 2025 results show a slow crawl due to CDRH staffing cuts |
Data source: FDA De Novo database (accessdata.fda.gov); historical cohort data derived from npj Digital Medicine (2024) census of FDA De Novo orders.
Key Takeaways from the Annual Trend
- The Post-2017 Expansion: Following the FDA's finalization of De Novo policies and the implementation of MDUFA IV, annual grants stabilized in the 30 to 45 range, compared to fewer than 15 per year in the pre-direct era.
- The 2024 Peak: The FDA granted 47 De Novo classifications in 2024, the highest annual total on record. That same year CDRH authorized 33 original Premarket Approvals (PMAs) and 4 Humanitarian Device Exemptions (HDEs). Together with first-of-a-kind 510(k) clearances, these made up CDRH's 120 novel device authorizations for the year. The telling comparison is between the novel-classification routes: at 47 grants, De Novos now outnumber original PMAs (33), confirming that for novel, lower-risk technologies without a predicate, the De Novo route has overtaken PMA.
- The 2025 Slowdown: The novel-device clearance rate slowed significantly in early 2025. Through Q1 2025, the FDA granted only 3 De Novo classifications, compared to 5 in Q1 2024. Industry reports attribute this "slow crawl" to CDRH workforce reductions and a backlog of complex software reviews.
2. Review Timelines: The Gap Between MDUFA Goals and Reality
Under the Medical Device User Fee Amendments (MDUFA V), the FDA committed to a performance goal of issuing a decision on a De Novo request within 150 FDA decision days for at least 70% of submissions.
However, "FDA decision days" do not represent calendar time. The FDA decision clock stops whenever the agency issues an Additional Information (AI) request, placing the submission on hold while the sponsor drafts a response. The calendar time required to achieve a De Novo grant is significantly longer.
By analyzing premarket authorization cohorts, we can compare the actual calendar time required to clear a De Novo against the time required for a Traditional 510(k):
Table 2: FDA Premarket Review Timelines in Practice (2024 Cohort)
| Premarket Pathway | Official MDUFA Goal (Decision Days) | Median Calendar Days to Decision | Primary Source of Hold/Delay |
|---|---|---|---|
| Traditional 510(k) | 90 days | 151 days | Refuse-to-Accept (RTA) holds, minor clinical data requests |
| De Novo Request | 150 days | 372 days | Major clinical evidence reviews, QMS audits, panel meetings |
| PMA (Class III) | 180 days | 240–320 days | Premarket QMS inspection (BIMO audits), panel reviews |
Data source: Median 510(k) and De Novo calendar review times are drawn from the 2024 peer-reviewed census of ML-enabled device authorizations (PMC); the PMA range reflects typical CDRH Class III review experience. "FDA decision days" exclude applicant-response (AI) hold time, so the calendar time to a decision is substantially longer than the MDUFA goal figure.
Why De Novo Review Takes a Full Year
- The Lack of a Predicate: Unlike a 510(k), where the sponsor simply proves "substantial equivalence" to a device that the FDA already understands, a De Novo sponsor must educate the agency. The FDA must review the safety profile from first principles and draft Special Controls (such as specific bench testing, labeling warnings, or clinical endpoints) that will govern this new category.
- The Clinical Data Requirement: While some Class II De Novos can be granted based on bench and animal testing, the vast majority of De Novo requests require human clinical data. Organizing, executing, and reporting a clinical study adds months to the pre-submission phase and extends the FDA’s review cycle as agency statisticians review the raw data.
- The Software Cohort Performance: In a study of Machine Learning (ML)-enabled devices authorized in 2024, only 9 out of 168 devices (5.4%) went through the De Novo pathway, while 159 used the 510(k) pathway. However, the median review time for those De Novo software applications was 372 days. The FDA’s scrutiny of novel algorithm-driven diagnostics remains exceptionally high, resulting in extensive AI holds.
3. Cost Comparison: De Novo vs. 510(k) vs. PMA
The administrative cost of filing a premarket submission is governed by the MDUFA user fee schedule, which is updated annually. Under MDUFA V, user fees have increased significantly to fund FDA staff expansion.
The table below outlines the MDUFA user fees for Fiscal Year 2025 (October 1, 2024 – September 30, 2025):
Table 3: FY2025 FDA Premarket User Fees
| Submission Type | Standard User Fee ($) | Small Business Fee ($) | Small Business Discount | eSTAR Requirement |
|---|---|---|---|---|
| Traditional 510(k) | $24,335 | $6,084 | 75% | Mandatory |
| De Novo Request | $162,235 | $40,559 | 75% | Mandatory |
| PMA (Class III) | $540,783 | $135,196 | 75% | Optional (select panels) |
Data source: FDA MDUFA V fee schedule for FY2025 (Federal Register notice 2024-16883). Under MDUFA V, the De Novo fee is set at 30% of the full PMA fee. Note: To qualify for the small business fee, a sponsor must obtain a Small Business Determination (SBD) certification showing gross receipts under $100 million.
The Evolution of the De Novo Fee
The De Novo user fee has grown faster than any other premarket category. To illustrate this progression, the chart below traces the standard De Novo fee over the last two MDUFA cycles:
- FY2018: $93,229
- FY2020: $102,299
- FY2022: $112,457
- FY2023: $132,464 (first MDUFA V year)
- FY2024: $145,068
- FY2025: $162,235
This rapid rise reflects the FDA's recognition of the resource-intensive nature of De Novo reviews. Because the agency must draft new regulations (the Special Controls) for each grant, the De Novo process functions similarly to a mini-PMA review.
For startups, this user fee makes early strategic planning essential. A filing error that results in a "Refuse to Accept" (RTA) or a "Not Granted" determination represents a significant financial loss.
4. Case Studies: Anatomy of Granted De Novos
To understand how De Novo classifications translate into regulatory and commercial reality, it is helpful to look at specific case studies. The three examples below show how novel tech uses the pathway:
Case Study 1: GI Genius (Intelligent Endoscopy Software)
- Premarket Number: DEN200055
- Granted Date: April 9, 2021
- Product Code: QNP (Gastrointestinal lesion software detection system)
- Special Controls Established: The FDA established extensive Special Controls, including mandatory clinical performance testing on representative patient cohorts, software verification and validation protocols, cybersecurity protections, and labeling instructions that detail the software's role as a secondary decision-support tool.
- Commercial Moat: GI Genius was the first device in this category. Any subsequent AI-enabled colonoscopy tool (such as those developed by competitors) could bypass the De Novo pathway and file a Traditional 510(k)—but they had to prove they met the strict QNP Special Controls, including demonstrating equivalent sensitivity and specificity to GI Genius.
Case Study 2: Dexcom G6 (Continuous Glucose Monitor)
- Premarket Number: DEN170088
- Granted Date: March 27, 2018
- Product Code: QBJ (Integrated Continuous Glucose Monitoring System, iCGM)
- Special Controls Established: The FDA established performance requirements for sensor accuracy across different glucose ranges, alarm reliability, cybersecurity for wireless transmissions, and clinical trial designs for pediatric and adult populations.
- Commercial Moat: By establishing the "iCGM" category, Dexcom not only cleared its own device but also defined the standard for the industry. Competitors like Abbott (FreeStyle Libre) had to align their clinical and bench data with these Special Controls to obtain their clearances, establishing a level playing field defined by Dexcom’s initial parameters.
Case Study 3: IDx-DR (AI Diabetic Retinopathy Diagnostic)
- Premarket Number: DEN180001
- Granted Date: April 11, 2018
- Product Code: PIB (Diabetic retinopathy detection device — retinal diagnostic software, 21 CFR 886.1100)
- Special Controls Established: The Special Controls required the sponsor to perform a prospective clinical study using a diverse screening population, document image quality metrics, and prove the software's autonomous diagnostic capability under real-world clinical conditions.
- Commercial Moat: IDx-DR pioneered autonomous AI diagnostics in ophthalmology. Its Special Controls created a highly structured pathway that subsequent developers of eye-screening AI had to follow, protecting the clinical baseline while allowing future 510(k) competitors to enter only under equivalent safety conditions.
5. Device Panel and Technology Concentration
Which specialties and medical technologies use the De Novo pathway most frequently? De Novo requests are assigned to the FDA’s advisory panels based on the clinical application of the device.
An analysis of the FDA's De Novo classification database reveals that the grants are highly concentrated in four primary advisory panel categories:
Table 4: Advisory Panels That Receive the Most De Novo Grants
| Advisory Committee Panel | Relative Volume | Common Novel Technologies | Example Granted De Novo |
|---|---|---|---|
| Gastroenterology / Urology | High | Diagnostic software, active endoscopes, home-use devices | GI Genius colonoscopy AI (DEN200055) |
| Clinical Chemistry / Toxicology | High | Continuous monitors, novel biomarkers, point-of-care tests | Dexcom G6 iCGM (DEN170088) |
| Ophthalmic | Moderate | Autonomous diagnostic software, screening algorithms | IDx-DR diabetic retinopathy AI (DEN180001) |
| General & Plastic Surgery | Moderate | Laser therapies, wound dressings, tissue adhesives | Active cooling systems for scar prevention |
| Microbiology | Moderate | Rapid molecular assays, antimicrobial-resistance detectors | Next-generation sequencing panels for pathogens |
| Other Panels (Neuro, Cardio, Ortho) | Moderate | Neuromodulators, structural heart guides, robotic assistants | Cranial electrical stimulators for insomnia |
Advisory panels are assigned by clinical application. Panel groupings and the example De Novo numbers above are drawn from the FDA De Novo database and published decision summaries; "Relative Volume" is a qualitative ranking, not a precise share, because grants span many panels and the mix shifts from year to year.
The Digital Health and eSTAR Mandate
A major driver of De Novo growth is Software as a Medical Device (SaMD). Because software applications often use novel algorithms, artificial intelligence, or machine learning, they frequently lack a predicate device with the same technological characteristics.
To manage this volume, the FDA has modernized its submission tools:
- The eSTAR Transition: Effective October 1, 2025, all De Novo classification requests must be submitted using the FDA's electronic Submission Template and Resource (eSTAR) PDF template, unless specifically exempted. eSTAR contains built-in databases and validation rules that align with the FDA's review templates, eliminating the traditional "Refuse to Accept" (RTA) screen.
- Special Controls for Software: Granted De Novo software classifications establish strict Special Controls detailing the cybersecurity, software validation, and predetermined change control protocols (PCCPs) that all future 510(k) applicants must follow.
6. Regulatory Quality Systems & Clinical Trial Diversity
Filing a De Novo is not just a regulatory submission; it requires a robust corporate infrastructure. As a De Novo sponsor, you must satisfy two critical requirements that do not apply to simple Class I self-certified products:
Quality Management System (QMSR) Compliance
Although you are exempt from a premarket notification, you are not exempt from quality system requirements. Under the FDA’s Quality Management System Regulation (QMSR), which took effect February 2, 2026, the FDA has incorporated ISO 13485:2016 by reference.
When you file a De Novo, you must declare compliance with the QMSR in your eSTAR package. The FDA reserves the right to conduct a premarket inspection of your manufacturing facility, particularly if your device involves complex manufacturing processes, sterile packaging, or active electronic components. Having a fully operational, ISO 13485-aligned quality system in place prior to submission is a prerequisite for a successful grant.
Clinical Trial Diversity Action Plans
Under the Food and Drug Omnibus Reform Act (FDORA), the FDA has implemented strict mandates for clinical trials. Any clinical study submitted to support a De Novo request must include a Diversity Action Plan (DAP).
The DAP must detail:
- The sponsor's enrollment goals for the clinical study, disaggregated by race, ethnicity, sex, and age group.
- The rationale for these goals, based on the demographics of the patient population in the United States affected by the target disease.
- A detailed strategy for how the sponsor will recruit and retain a diverse cohort (e.g., using decentralized trial methods, providing translation services, or placing study sites in diverse urban areas).
Sponsors who fail to submit a DAP or fail to meet their diversity goals without a documented, FDA-approved waiver face significant review holds during the clinical data audit.
7. Strategic Implications for MedTech Sponsors in 2026
If you are developing a novel device, how should you evaluate the De Novo pathway in 2026?
1. Build a Regulatory Moat
While the De Novo pathway is expensive ($162,235 standard fee) and slow (~372 days), it offers a massive commercial advantage: it establishes the regulatory baseline for your market. As the first granted device, your Special Controls define the testing, clinical, and performance standards that all future competitors must meet. If your Special Controls require extensive clinical evidence or complex testing, you have effectively built a regulatory barrier that competitors must fund and execute to obtain a 510(k).
2. Leverage the eSTAR Template Early
Do not treat eSTAR as a final formatting step. Download the eSTAR template at the start of your product design cycle. Use its structured fields to guide your verification and validation testing, ensuring you collect the exact data the FDA expects.
3. Use Q-Submissions to De-Risk the Filing
Because the FDA only grants about half of the De Novo requests submitted (with the rest placed on hold or rejected as NSE), you should never file "blind." Use the Q-Submission program to request a pre-submission meeting with the FDA. Present your proposed clinical study design and bench testing protocol to the agency. Securing FDA alignment on your testing plan before you file is the single most effective way to avoid a costly "Not Granted" decision.
FDA De Novo Database FAQ
What is a De Novo classification request and who should file one?
A De Novo request is a regulatory submission to the FDA for a novel medical device that carries low-to-moderate risk but has no existing predicate device on the US market. Sponsors who would otherwise face an automatic Class III (PMA) classification should file a De Novo to request that the FDA create a new Class I or Class II classification for their product.
How much does a De Novo cost in FDA user fees for FY2025?
For Fiscal Year 2025, the standard FDA De Novo submission user fee is $162,235. For companies that qualify for Small Business Status (gross receipts under $100 million), the discounted fee is $40,559.
Is eSTAR required for De Novo submissions?
Yes. As of October 1, 2025, all De Novo classification requests must be submitted electronically using the FDA’s eSTAR template. Submissions sent in the legacy paper or eCopy formats will be rejected.
Can I submit a De Novo after a 510(k) NSE determination?
Yes. This was the original, mandatory route. While most sponsors now use the Direct De Novo pathway, you can still submit a De Novo request within 30 days of receiving a Not Substantially Equivalent (NSE) determination on a Traditional 510(k).
How does a granted De Novo become a predicate for future 510(k)s?
When the FDA grants a De Novo request, it publishes a new regulation in the Code of Federal Regulations (CFR) and issues a new product code. The granted device is placed in Class I or Class II. Any future manufacturer introducing a similar device can then file a Traditional 510(k) using the granted De Novo device as their predicate, proving "substantial equivalence" to bypass the De Novo process.
Data sources: FDA De Novo classification database (accessdata.fda.gov); FY2025 MDUFA V user-fee schedule (Federal Register notice 2024-16883); peer-reviewed De Novo cohort analyses (npj Digital Medicine, 2024; PMC, 2024); and the case-study De Novo decision summaries for DEN170088 (Dexcom G6), DEN180001 (IDx-DR), and DEN200055 (GI Genius). Annual grant counts for years prior to 2024 are drawn from the published npj Digital Medicine census of FDA De Novo orders and the FDA database; 2025 figures are partial (Q1) and reflect CDRH staffing changes. This article is educational and is not regulatory advice for a specific product or submission.