The De Novo pathway lets FDA classify a novel device into Class I or II when no predicate exists, so it can reach the market without a PMA. The FDA fee is $191,020 from October 1, 2026, and De Novos granted from 2023 to 2025 took a median of 319 calendar days.

Key takeaways

  • A De Novo request classifies a novel device into Class I or II when there is no legally marketed predicate. Once granted, the device can serve as a predicate for future 510(k)s.
  • One in four De Novos granted from 2023 to 2025, 30 of 121, appears on FDA's list of authorized Breakthrough devices.
  • FDA granted 47 De Novo requests in 2024 and 27 in 2025. Those granted from 2023 to 2025 took a median of 319 calendar days from receipt.
  • FDA decides whether to accept a request within 15 days. For fiscal year 2027, its goal is a decision within 150 FDA days for 90% of requests.
  • Apple's 2018 ECG app De Novo created product code QDA. Since 2020, FDA has cleared 8 510(k)s under that code, from Apple and five other companies.

What is the FDA De Novo pathway?

It is FDA's route for classifying a novel device that has no predicate. De Novo classifies devices for which general controls, or general and special controls, give reasonable assurance of safety and effectiveness, but for which no legally marketed predicate exists [2].

Without a predicate, a new device cannot use a 510(k). By law, a device first marketed after May 28, 1976 is placed in Class III unless it is substantially equivalent to a classified device, is reclassified, or is classified through a De Novo request [8]. That default is why FDA calls De Novo the evaluation of automatic Class III designation [2]. A device that is Class III by default must have an approved Premarket Approval (PMA) application before it can be sold [9]. The rules are in 21 CFR Part 860, Subpart D [1].

A granted De Novo becomes a predicate. FDA states that devices classified through a De Novo request may be marketed and used as predicates for future 510(k)s, when applicable [2]. Our De Novo overview summarizes the essentials.

When should you choose De Novo?

When no predicate fits and your device's risk suits Class I or II. You can file a De Novo request in two ways [1]:

  1. After FDA finds your 510(k) not substantially equivalent to its predicate.
  2. Directly, when you determine there is no legally marketed device to base a 510(k) on.

Check that the route is open first. FDA may decline a De Novo request if your device type has already been classified into Class I, II or III, or has already been approved through a PMA [1]. If a De Novo already exists for your device type, you may be able to file a 510(k) against it instead.

Route When it fits FDA fee from October 1, 2026 FDA review goal
510(k) A predicate exists $28,653 90 FDA days for 95% of submissions
De Novo No predicate; the device suits Class I or II $191,020 150 FDA days for 90% of requests in fiscal year 2027
PMA Class III $636,732 180 FDA days for 90% of original PMAs without an advisory panel

Sources: FY2027 fee notice [3]; MDUFA V commitment letter [4]. Small business fees are lower: $7,163 for a 510(k) and $47,755 for a De Novo [3].

The question "is there a predicate?" decides the route, and it is harder than it looks. Complizen's Superagent has a Predicate Finder that ranks candidate predicates by similarity, so you can test the question before you commit to a De Novo. Our guide to predicate devices explains what makes a predicate usable.

How do you prepare a De Novo request, step by step?

Work through these steps in order.

  1. Confirm no predicate and no existing classification. Search FDA's classification, 510(k) and De Novo databases for your device type.
  2. Confirm your device suits Class I or II. Decide which general and special controls would give reasonable assurance of safety and effectiveness.
  3. Ask FDA first. FDA recommends that sponsors consider a Pre-Submission before filing a De Novo request [2]. Our Q-Submission guide explains how.
  4. Build the evidence. Plan the bench, software, biocompatibility and, where needed, clinical data your proposed controls call for. Our clinical trials guide covers studies.
  5. Apply for small business status if your gross receipts are $100 million or less, to pay $47,755 instead of $191,020 [3].
  6. Prepare the request in eSTAR. Since October 1, 2025, De Novo requests must be submitted through eSTAR, unless exempted [2].
  7. Answer FDA quickly. You have 180 days to respond fully to a request for more information, or FDA treats the request as withdrawn [1].

The free pathway finder gives a first view of whether De Novo, a 510(k) or a PMA fits your device.

What goes into a De Novo request?

The regulation lists what a De Novo request must include, unless you justify an omission [1]. Beyond administrative details, the core items are:

  • your regulatory history, the device name, indications for use and a device description
  • alternative practices and procedures
  • a classification summary and a classification recommendation
  • a summary of risks and how you mitigate them
  • your proposed special controls
  • the standards you rely on, and summaries of your studies
  • benefit and risk considerations, and the technical sections
  • labeling and any advertisements

Give your proposed special controls the most care. If FDA grants the request, the controls it sets become the rules every later device of that type must meet [1]. A requester outside the US also lists a US representative, where applicable [1].

How does FDA review a De Novo request?

In three stages, each with a clock.

Acceptance, within 15 days. FDA tells you within 15 days whether it accepts the request for substantive review. If FDA does not finish the acceptance review in that time, the request is accepted [1].

Substantive review, with a 120-day target in the regulation. FDA will review the request and grant or decline it within 120 days of receipt or acceptance [1]. Separately, FDA's MDUFA V performance goal is a decision within 150 FDA days for 70% of requests [4]. That goal rises to 90% for fiscal year 2027, which starts October 1, 2026, because FDA met its fiscal year 2024 De Novo goal and the fiscal year 2027 fees include the extra funding the agreement requires [3, 4].

A decision, published if granted. If FDA grants the request, it publishes the classification order, with any special controls, in the Federal Register within 30 days [1]. If it declines, it issues a written order [1].

Why FDA declines. Reasons include a device that does not meet the Class I or II criteria, a false statement or material omission, non-compliant labeling, or a device type that is already classified or already approved through a PMA [1].

How long does a De Novo take in practice?

Longer than the review goals suggest, because FDA days pause while FDA waits for your answers [4]. We ran a count on September 25, 2026 of every De Novo FDA granted from 2023 to 2025: 121 requests [5].

Year granted De Novos granted Median calendar days from receipt to decision
2023 47 326
2024 47 328
2025 27 299

Source: our analysis of FDA's De Novo records via openFDA, which match FDA's De Novo database for 2024 and 2025 [5, 6]. These counts cover granted requests only.

Across all three years, the middle half took 230 to 376 days, and 26% took more than a year [5]. That is about 10 to 11 months from filing to decision, and the figure already includes time spent answering FDA's questions.

What does a De Novo cost?

The FDA fee is fixed; the rest depends on your evidence. From October 1, 2026, the De Novo fee is $191,020, or $47,755 for a qualifying small business [3]. That is about 6.7 times the standard 510(k) fee of $28,653 [3].

Testing, any clinical study and preparation time come on top, and depend on your evidence. Our guides to 510(k) costs and medical device clinical trial costs cover those lines, and our FDA user fees page lists every current fee.

What happens after a De Novo is granted?

Your device gets its own classification regulation and product code, and becomes a predicate that later devices can use [1, 2]. That turns the first mover's cost into a path for everyone after.

A real example: the ECG app. In 2018, FDA granted Apple's De Novo for its ECG App, creating regulation 21 CFR 870.2345 and product code QDA [7]. Since August 2020, FDA has cleared 8 510(k)s under QDA, from Apple, Samsung, Fitbit, Garmin, Whoop and Withings [5]. Each of them used a 510(k) within the category that Apple's De Novo created, at a fraction of the De Novo fee.

This is what special controls look like. The regulation the ECG App De Novo created, 21 CFR 870.2345, sets five special controls [10]:

  1. Clinical performance testing, including the detection algorithm's sensitivity and either specificity or positive predictive value.
  2. Software verification, validation and hazard analysis.
  3. Non-clinical testing of the algorithm on a previously adjudicated data set.
  4. Human factors testing showing users can operate the device from its labeling alone and know when to seek medical care.
  5. Specific labeling, such as platform requirements and situations where performance may drop.

Every later ECG app had to meet the same five. That is why your proposed special controls deserve the most care: if granted, they become the rules for your whole device type.

The lesson cuts both ways. Being first builds the category, but followers can enter by 510(k). If a De Novo already exists for your device type, check whether a 510(k) against it fits before you plan a De Novo of your own. Our guide to FDA's medical device databases shows how to search the De Novo database.

Can the Breakthrough Devices Program speed up a De Novo?

It is designed to speed up development, assessment and review, and it covers De Novo requests as well as 510(k)s and PMAs [11]. A device qualifies if it offers more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition [11]. It must also meet at least one of four further criteria [11]:

  • it represents breakthrough technology
  • no approved or cleared alternatives exist
  • it offers significant advantages over existing alternatives
  • its availability is in the best interest of patients

You can request designation at any time before you send your marketing submission [11]. As of June 30, 2026, FDA had granted 1,320 designations and authorized 210 Breakthrough devices: 91 through 510(k), 63 through PMA and 51 through De Novo, with 5 more authorized by FDA's biologics center, by our count of FDA's list [11].

Many De Novo devices qualify. Of the 121 De Novos granted from 2023 to 2025, 30 appear on FDA's list of Breakthrough devices authorized for their designated use, about one in four [5, 11]. Our Breakthrough Devices Program guide explains how to request designation.

Can manufacturers outside the US use De Novo?

Yes, but few do. Of the 121 De Novos granted from 2023 to 2025, 83 went to applicants based in the US [5]. Israel had 10, the United Kingdom 6, France and Ireland 4 each, Australia 3, and Canada and South Korea 2 each [5].

The rules are the same wherever you are based. Plan the Pre-Submission early, and staff a team that can answer FDA's questions quickly, since you have 180 days to respond to each request [1]. Complizen's Regulatory Strategy sets out your class, pathway and predicates in writing, which is the decision a De Novo depends on.

Frequently asked questions

What is an FDA De Novo?

A De Novo request asks FDA to classify a novel device into Class I or II when no legally marketed predicate exists. Without it, the device would need a PMA. Once granted, the device gets its own classification regulation and can serve as a predicate for future 510(k)s.

How much does a De Novo cost?

The FDA fee is $191,020 from October 1, 2026, or $47,755 for a qualifying small business with gross receipts of $100 million or less. Testing, any clinical study and preparation time come on top, and depend on your device and the evidence it needs.

How long does a De Novo take?

De Novos granted from 2023 to 2025 took a median of 319 calendar days from receipt to decision, and 26% took more than a year. FDA's goal is 150 FDA days, but FDA days pause while FDA waits for your answers.

What is the difference between a De Novo and a 510(k)?

A 510(k) shows your device is substantially equivalent to a legally marketed predicate. A De Novo classifies a novel device that has no predicate. The De Novo fee is about 6.7 times the 510(k) fee, and in 2025 the median De Novo took 299 days against 126 for a 510(k).

What is the difference between a De Novo and a PMA?

A De Novo places a novel device in Class I or II, where general and special controls are enough. A PMA is for Class III devices and requires FDA's approval of an application showing safety and effectiveness. From October 1, 2026, the PMA fee is $636,732, against $191,020 for a De Novo.

Do I need a 510(k) rejection before filing a De Novo?

No. You can file a De Novo request after FDA finds a 510(k) not substantially equivalent, or directly when you determine no legally marketed predicate exists. FDA recommends considering a Pre-Submission before either route. The direct route saves the time and fee of a 510(k) you expect to fail.

How many De Novo requests does FDA grant each year?

FDA granted 47 De Novo requests in 2023, 47 in 2024 and 27 in 2025, according to its De Novo records. These counts cover granted requests only, so they do not show how many requests were declined or withdrawn. FDA's records showed 25 more granted in 2026 by mid-September.

Can a De Novo device be used as a predicate?

Yes. FDA states that devices classified through De Novo may be marketed and used as predicates for future 510(k)s. Apple's 2018 ECG App De Novo created product code QDA, and FDA has since cleared 8 510(k)s under it, from Apple and five other companies.

Why does FDA decline De Novo requests?

FDA may decline a request if the device does not meet the Class I or II criteria, the request contains a false statement or material omission, the labeling does not comply, or the device type is already classified or approved through a PMA.

Is eSTAR required for De Novo requests?

Yes. Since October 1, 2025, De Novo requests must be submitted as electronic submissions using eSTAR, unless exempted. FDA also checks whether a request is complete enough to accept within 15 days of receiving it. If FDA misses that 15-day deadline, the request is accepted.

Can a company outside the US file a De Novo request?

Yes. The rules are the same, and a requester outside the US lists a US representative where applicable. Of 121 De Novos granted from 2023 to 2025, 38 went to applicants based outside the US, including 2 from South Korea.

What are special controls in a De Novo?

Special controls are the device-specific requirements, beyond general controls, that give reasonable assurance of safety and effectiveness for a Class II device. A De Novo request proposes them, and once FDA grants it, they apply to every later device of that type.

References

  1. eCFR. 21 CFR Part 860, Subpart D, De Novo Classification. Text current as of September 1, 2026.
  2. FDA. De Novo Classification Request. Content current as of September 30, 2025.
  3. Federal Register. Medical Device User Fee Rates for Fiscal Year 2027, 91 FR 48134. Published July 30, 2026.
  4. FDA. MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027 (MDUFA V commitment letter).
  5. openFDA. Device API: 510(k) endpoint, De Novo decisions. Checked September 25, 2026.
  6. FDA. De Novo Database. Checked September 25, 2026.
  7. FDA. De Novo record DEN180044, ECG App. Decision date September 11, 2018.
  8. Legal Information Institute, Cornell Law School. 21 U.S.C. 360c, Classification of devices intended for human use (FD&C Act section 513). Accessed September 25, 2026.
  9. Legal Information Institute, Cornell Law School. 21 U.S.C. 360e, Premarket approval (FD&C Act section 515). Accessed September 25, 2026.
  10. eCFR. 21 CFR 870.2345, Electrocardiograph software for over-the-counter use. Accessed September 25, 2026.
  11. FDA. Breakthrough Devices Program. Content current as of August 31, 2026; data as of June 30, 2026.