FDA's De Novo database is a public list of granted De Novo requests, with records from 1998 onward. Our count of FDA's openFDA data found 490 grants through September 29, 2026, and the database does not show requests that FDA declined.
Key takeaways
- openFDA holds 490 granted De Novo records from CDRH, FDA's device center, dated May 29, 1998 to September 29, 2026 [7].
- Only 2 of the 490 list a requester address in South Korea, and none in Japan, Taiwan, India, Malaysia, Turkey or the Gulf [7].
- 296 of the 487 De Novo product codes (61%) later had at least one 510(k) cleared under the same code [7].
- Of 83 requests CDRH accepted from fiscal year 2023, it granted 37 and declined 18, and 28 were withdrawn or deleted [5].
- The median time from receipt to grant was 324 calendar days for 199 grants since January 2021 [7].
What is the FDA De Novo database?
The De Novo database is FDA's public search tool for devices classified through a granted De Novo request. A De Novo request is the route for a novel device with no predicate. General controls, or general and special controls, must be able to provide reasonable assurance of safety and effectiveness [2].
If FDA grants the request, the device goes into class I or class II. FDA says these devices may then be marketed and used as predicates for future 510(k)s, when applicable [2]. So each record marks the start of a new device type. FDA's current De Novo rules are in 21 CFR Part 860, Subpart D, from a final rule effective January 3, 2022 [6].
You can open the search page on FDA's website [1]. It sits alongside the 510(k), PMA and classification databases. If you want to compare all of them, read our guide to FDA's device databases.
How do you search the De Novo database?
Start with the product code if you have it, then widen to device name and panel. The search page has these fields [1]:
| Field | Use it when |
|---|---|
| De Novo Number | You already have a number, such as DEN170073 |
| Device Name | You know a trade name or a word in it |
| Requester Name | You are checking a competitor |
| Panel | You want every grant in a specialty, such as Radiology |
| Product Code | You know the three-letter code |
| Decision Date | You want recent grants only |
| Predetermined Change Control Plan Authorized | You want grants that include a change plan |
| Priority Review | You want to filter by priority review status |
| Center | You want CDRH or CBER, FDA's biologics center |
| 510(k) Number | You want to find a linked 510(k) |
Follow these steps for a useful search:
- Search one word from your device type in Device Name. Do not type a full sentence.
- Open the closest record and note the Regulation Number and Product Code.
- Search that Product Code alone to see every grant under it.
- Open the Classification Order and the Decision Summary for each close match.
- Search the same Product Code in the 510(k) database to see who followed.
What does a De Novo record show?
Each record gives the regulation, product code and dates, and many link to two key documents. We use ContaCT as an example, because that one grant created a device type many others now use [8].
| Record field | ContaCT (DEN170073) |
|---|---|
| Requester | Viz.AI |
| Regulation Number | 21 CFR 892.2080 |
| Product Code | QAS |
| Date Received | September 29, 2017 |
| Decision Date | February 13, 2018 |
| Decision | Granted (DENG) |
| Type | Direct |
| Predetermined Change Control Plan Authorized | No |
The two linked PDFs matter most. The Classification Order is FDA's formal order. The Decision Summary explains the data FDA reviewed. The ContaCT summary runs to 18 pages and maps testing to each special control [8].
Do not expect both PDFs on every record. On November 2, 2026, 23 of the 26 grants from 2026 had no Decision Summary link, and older records may lack one too. If a recent grant has no summary, check back later.
Special controls are the device-specific requirements for a class II type. They now appear in the regulation, so they apply to every later device of that type [9]. For QAS, read 21 CFR 892.2080 before you plan any testing [9].
Why should you search it before you file anything?
Search it first because the result can change your pathway. A match may mean you can use a 510(k), and its FDA fee is far lower.
- FDA may decline a repeat. FDA may decline a De Novo request if the device is of a type already classified [3].
- The fee gap is large. For fiscal year 2027, a De Novo request costs $191,020 and a 510(k) costs $28,653. Small business rates are $47,755 and $7,163 [10].
- The Decision Summary shows the evidence FDA accepted. That helps you plan tests before you pay a lab.
- A grant can become your predicate. The QAS code now has 88 cleared 510(k)s after ContaCT [7].
Not sure which route fits? Our pathway finder gives a first answer, and our De Novo, 510(k) and PMA comparison explains the trade-offs.
Keyword searches can miss a close match, because device names often do not describe the technology. Complizen's predicate research includes a De Novo precedent search alongside 510(k) predicates, which is a quick way to test your manual search. It helps you check whether a device like yours has already been classified.
How many De Novo requests does FDA grant each year?
FDA's data shows between 22 and 47 grants a year since 2019. These are calendar-year counts by decision date [7].
| Decision year | Grants | Median days, receipt to grant |
|---|---|---|
| 2019 | 22 | 320 |
| 2020 | 26 | 296 |
| 2021 | 30 | 310.5 |
| 2022 | 22 | 331 |
| 2023 | 47 | 326 |
| 2024 | 47 | 328 |
| 2025 | 27 | 299 |
| 2026, to September 29 | 26 | 328 |
The days above are calendar days and include time on hold. They are longer than FDA's own review clock. The regulation says FDA will send its decision within 120 days [4]. The user fee goal is to decide 80% of requests within 150 FDA days in fiscal year 2026, and 90% in fiscal year 2027 [5]. FDA days exclude the time a request is on hold for additional information [2].
The most recent grants include AI software. Examples from 2026 are neuropacs, DeepView AI System and Queen of Hearts (ACS AI ECG Model) [7].
How many De Novo requests does FDA decline?
The database will not tell you, because every record we counted is a grant. FDA's quarterly user fee report gives CDRH numbers for accepted requests, as of June 30, 2026 [5].
| Fiscal year received | Requests with a decision | Granted | Declined | Withdrawn | Deleted | Still pending |
|---|---|---|---|---|---|---|
| 2023 | 83 | 37 | 18 | 17 | 11 | 0 |
| 2024 | 72 | 29 | 18 | 13 | 12 | 0 |
| 2025 | 50 | 28 | 7 | 5 | 10 | 12 |
Fiscal year 2025 is not final, because 12 requests were still pending in that report. FDA's report shows a grant rate of 44.58% for fiscal year 2023 and 40.28% for fiscal year 2024. In that report, "decision" includes withdrawals and deletions [5].
The report's De Novo tables do not define "deleted". FDA's De Novo page covers additional information requests. Without a complete answer within 180 days, FDA considers the request withdrawn and deletes it from its review system [2]. You then need a new request [2]. FDA's rules list other reasons to decline, including a false statement, labeling problems or a device that does not meet class I or II criteria [3].
Which countries do De Novo requesters come from?
The US leads with 375 of the 490 grants. The other 115 (23%) list a requester outside the US [7].
| Requester country | Grants |
|---|---|
| United States | 375 |
| Israel | 27 |
| United Kingdom | 17 |
| Canada | 16 |
| Ireland | 9 |
| France | 7 |
| South Korea | 2 |
| Japan, Taiwan, India, Malaysia, Turkey, Saudi Arabia, UAE | 0 |
The two South Korean grants are the Samsung Sleep Apnea Feature (DEN230041, February 6, 2024) and OcuCool from Recensmedical (DEN230011, September 30, 2024) [7].
So FDA's data shows only 2 grants across South Korea, Japan, Taiwan, India, Malaysia, Turkey, Saudi Arabia and the UAE. Some global groups file through a US company, and this count uses the address on the record. These markets do use the route a De Novo opens. Later 510(k)s under De Novo product codes include 41 from South Korea, 16 from Japan, 10 from Taiwan, 4 from India and 1 from Turkey [7].
If your device looks novel, confirm this with FDA early. FDA recommends that sponsors consider a Pre-Submission before they file a De Novo request [2]. Since October 1, 2025, De Novo requests must use the eSTAR template, unless exempted [2, 11].
What does the De Novo database not show?
It does not show declined, withdrawn, deleted or pending requests. It also does not tell you whether a device is on the market today [1, 5].
| You want to know | Where to look |
|---|---|
| Declined and withdrawn totals | FDA's quarterly MDUFA report [5] |
| Later 510(k)s under the code | FDA's 510(k) database |
| Whether a firm is registered and listed | FDA's registration and listing database |
| New De Novo classifications | The Federal Register. The rule says FDA will publish a notice within 30 days after the order [3], but notices can come much later |
| Bulk data | openFDA [7]. The Download Files link on the search page opens FDA's 510(k) files page [1] |
You can pull the CDRH grants openFDA holds with one API call. Use decision_code:DENG as the search, on the 510(k) endpoint [7].
Do not rely on the Federal Register for timing. A notice published October 30, 2026 covers Fibresolve, a radiology software device with a decision date of January 12, 2024 [7, 12].
How we counted
We counted records in openFDA's 510(k) dataset with decision code DENG. We used the bulk file dated October 30, 2026, which FDA's data marks as last updated October 19, 2026 [7]. We found 490 records with 487 distinct product codes.
Country means the country in the requester's address, which may differ from where the device is made. Days run from date received to decision date. For later 510(k)s, we counted 510(k) records with a decision date after the first De Novo grant under that product code. That gave 1,926 records under 296 codes.
On November 2, 2026, the live database showed 492 CDRH records, plus records from CBER that openFDA omits. openFDA lags the live search by a few weeks.
We did not read each 510(k) to confirm it used the De Novo device as its predicate. openFDA states that its data is not validated.
What should you do next?
Search your device type today, then read the Decision Summary of the closest grant. If you find a match, consider a 510(k). If you find nothing, your next question is whether your device is truly novel.
The FDA fee alone is $191,020, so test that answer before you commit [10]. Start with our De Novo overview, then ask for a gap assessment if the answer is still unclear.
Frequently asked questions
Is the FDA De Novo database free to use?
Yes, the FDA De Novo database is free and needs no account. Anyone can search it on FDA's website and open the Classification Order and Decision Summary where FDA has posted them. Bulk data is also free through openFDA, although FDA states that openFDA results are not validated.
How many De Novo requests has FDA granted?
openFDA held 490 granted De Novo records through September 29, 2026, by our count, running back to May 1998. The live database showed slightly more on November 2, 2026, including October grants and biologics records, so check the date on any count you quote.
Does the De Novo database show declined requests?
No, the database lists granted requests only. Every one of the 490 records we counted carried the granted code DENG. To see declined totals, use FDA's quarterly MDUFA performance report, which gives numbers for each fiscal year but does not name the requesters.
What does DENG mean in FDA data?
DENG is FDA's decision code for a granted De Novo request. You will see it in the De Novo database and in openFDA's 510(k) data. In openFDA, search decision_code:DENG on the 510(k) endpoint to list these records in one query.
Is a De Novo device cleared or approved?
Neither word is correct: FDA grants a De Novo request. A 510(k) is cleared and a PMA is approved. After the grant, the device is class I or class II, and later devices of that type may reach the market through a 510(k).
Can I use a De Novo device as my 510(k) predicate?
Yes, FDA says devices classified through De Novo may be used as predicates for future 510(k)s, when applicable. You still must show substantial equivalence. That includes the same intended use, and you must meet any special controls in the regulation.
Where do I find the special controls for a De Novo device?
Look in the classification regulation named on the record, such as 21 CFR 892.2080. The Classification Order also lists them. Read the Decision Summary as well, because it shows how the first requester addressed each special control with test data.
What is the difference between Direct and Post-NSE?
Direct means the requester filed the De Novo request without a 510(k) first. Post-NSE means it followed a not substantially equivalent decision on a 510(k). In FDA's data, 380 of the 490 grants are Direct and 110 are Post-NSE, by our count.
How long does a De Novo request take?
The median was 324 calendar days from receipt to grant for 199 grants since January 2021, by our count. This includes hold time. FDA's user fee goal is 150 FDA days, which excludes holds. Neither figure predicts the time for your device.
How much does a De Novo request cost in fiscal year 2027?
The FDA fee is $191,020 for fiscal year 2027, from October 1, 2026. The small business fee is $47,755. FDA updates these fees every fiscal year, so check the current notice. The fee does not include testing, clinical work or preparation costs.
Can a foreign manufacturer submit a De Novo request?
Yes, nothing in FDA's data limits requesters to the US: 115 of 490 grants list a requester outside the US. Foreign approval does not help directly, because FDA does not recognize authorizations from other countries. Your evidence must meet FDA's requirements for your device.
How do I know if a new De Novo has been granted?
Check the database and sort by decision date, descending. The rule says FDA will publish a Federal Register notice within 30 days after the order, but notices can come much later. The notice is still useful, because it gives the new regulation and its special controls.
References
- FDA. Device Classification Under Section 513(f)(2) (De Novo) database. Page last updated November 2, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm
- FDA. De Novo Classification Request. Content current as of September 30, 2025. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request
- 21 CFR 860.260, Granting or declining a De Novo request (2025 edition). https://www.govinfo.gov/content/pkg/CFR-2025-title21-vol8/pdf/CFR-2025-title21-vol8-sec860-260.pdf
- 21 CFR 860.240, Procedures for review of a De Novo request (2025 edition). https://www.govinfo.gov/content/pkg/CFR-2025-title21-vol8/pdf/CFR-2025-title21-vol8-sec860-240.pdf
- FDA. MDUFA V Performance Report, third quarter fiscal year 2026, Section 8. August 26, 2026. https://www.fda.gov/media/194465/download?attachment
- FDA. Medical Device De Novo Classification Process, final rule. 86 FR 54826, October 5, 2021, effective January 3, 2022. https://www.federalregister.gov/documents/2021/10/05/2021-21677/medical-device-de-novo-classification-process
- openFDA. Device 510(k) endpoint and bulk download, last updated October 19, 2026, pulled November 2, 2026. https://open.fda.gov/apis/device/510k/
- FDA. De Novo decision summary, ContaCT, DEN170073. Decision date February 13, 2018. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170073.pdf
- 21 CFR 892.2080, Radiological computer aided triage and notification software (2025 edition). https://www.govinfo.gov/content/pkg/CFR-2025-title21-vol8/pdf/CFR-2025-title21-vol8-sec892-2080.pdf
- FDA. Medical Device User Fee Rates for Fiscal Year 2027. 91 FR 48134, July 30, 2026. https://www.federalregister.gov/documents/2026/07/30/2026-15335/medical-device-user-fee-rates-for-fiscal-year-2027
- FDA. Electronic Submission Template for Medical Device De Novo Requests, final guidance. August 23, 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-de-novo-requests
- FDA. Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung Disease. 91 FR 68467, October 30, 2026. https://www.federalregister.gov/documents/2026/10/30/2026-22180/medical-devices-radiology-devices-classification-of-the-radiology-software-for-referral-of-findings