An HHS-funded study estimated $1.4 million for a feasibility study and $30.7 million for a pivotal trial of a novel high-risk device, in 2018 dollars. Most device trials are far smaller: by our count, industry device studies completed from 2023 to 2025 enrolled a median of 56 patients.
Key takeaways
- An HHS-funded study costed a novel high-risk device's feasibility study at $1.4 million and its pivotal trial at $30.7 million, or $34,059 and $54,332 per patient in 2018 dollars.
- Most device trials are much smaller. Across 1,747 industry device studies completed from 2023 to 2025, the median enrolled 56 patients and took 12.6 months to reach primary completion.
- 56% of those studies had no US site. FDA accepts data from studies outside the US if they follow good clinical practice and FDA can validate the data.
- A non-significant-risk study needs IRB approval but no FDA application. A significant-risk study can start 30 days after FDA receives its IDE, unless FDA objects.
- Most 510(k)s include no clinical data. In an FDA sample, 14% did.
How much does a medical device clinical trial cost?
A detailed public estimate comes from a 2022 study funded by the US Department of Health and Human Services and published in JAMA Network Open [1]. It modeled novel therapeutic devices that go through FDA's Premarket Approval (PMA) route.
| Study stage | Average cost | Patients | Duration | Cost per patient |
|---|---|---|---|---|
| Feasibility study | $1.4 million | 42 | 28.0 months | $34,059 |
| Pivotal study | $30.7 million | 565 | 56.9 months | $54,332 |
| Post-approval study | $6.0 million | 414 | 81.2 months | $14,416 |
Source: Sertkaya and colleagues, JAMA Network Open, 2022, in 2018 dollars. Per-patient costs come from Medidata Solutions data [1].
The pivotal study dominates the budget. In that model, the pivotal study alone was 57% of the $54 million out-of-pocket development cost [1]. Our guide to medical device development costs covers the rest of that budget.
Treat these as high-end figures. They describe novel high-risk devices on the PMA route, not the typical Class II device. Our clinical trials guide covers the wider topic.
How big are most device trials?
Much smaller than a PMA pivotal trial. We ran a count on September 25, 2026 of every completed, industry-sponsored interventional device study on ClinicalTrials.gov with a primary completion date from 2023 to 2025: 1,747 studies [2].
| Patients enrolled | Share of studies |
|---|---|
| Fewer than 50 | 44% |
| 50 to 199 | 40% |
| 200 to 499 | 11% |
| 500 or more | 4% |
Source: our analysis of ClinicalTrials.gov records, actual enrollment [2]. These are all completed industry studies that list a device intervention, including postmarket and non-regulatory studies, not only those that supported an FDA submission.
The typical study is small and short. The median study enrolled 56 patients, and the middle half enrolled 28 to 135 [2]. The median took 12.6 months from start to primary completion. Half ran at a single site, and 41% were randomized [2].
Size drives cost. In the HHS model, each stage's cost is its number of patients multiplied by its cost per patient: 565 patients at $54,332 gives the $30.7 million pivotal figure [1]. Use the same arithmetic as a first check on your own budget. For illustration, a 56-patient study at the model's feasibility cost of $34,059 per patient comes to about $1.9 million in 2018 dollars [1, 2]. That per-patient figure comes from studies of complex, high-risk devices. Your per-patient cost may be far lower or higher, so price it with quotes from your sites.
Do you need a clinical study at all?
Usually not, for a 510(k). In FDA's own random sample of 510(k)s submitted in fiscal year 2009, 14% included any clinical data [3].
FDA's draft guidance on clinical data in 510(k)s, issued September 7, 2023, describes four situations where clinical data may be needed [4]:
- Your indications for use differ from the predicate's.
- Your technological characteristics differ from the predicate's.
- Substantial equivalence cannot be shown by non-clinical testing.
- A new or increased risk has been identified for the predicate.
The guidance is a draft, so treat it as FDA's current thinking, not a binding rule.
Existing data can sometimes stand in. FDA's final guidance on using real-world evidence for medical devices, issued in December 2025, explains how FDA evaluates evidence from sources other than a new trial [11]. Ask about it in your Pre-Submission if you already have registry or clinical-use data.
Ask FDA before you spend. A Pre-Submission lets you get FDA's feedback on whether you need a study, and on its design, before you commit a budget. FDA's fee schedule lists no fee for it [6]. FDA's goal is to send written feedback within 70 calendar days of receiving the request, or five days before a scheduled meeting if that is sooner [9]. FDA reports that it met that goal in fiscal year 2025 [6]. Complizen's Superagent includes a Q-Sub Request Drafter for preparing that request, and our Q-Submission guide covers the process.
What drives the cost of a device clinical trial?
Five things decide most of the budget.
- Patients. Cost scales with enrollment. The HHS model priced a pivotal patient at $54,332 and a feasibility patient at $34,059 [1].
- Duration. Longer enrollment and follow-up mean more months of site, monitoring and data costs. The model's pivotal study ran 56.9 months [1].
- Sites. Each site adds contracts, training and monitoring. Half of recent industry device studies used one site [2].
- Design. Randomized studies need a control group, which adds patients. 41% of recent industry device studies were randomized [2].
- Risk level. A significant-risk device needs an FDA-approved investigational device exemption (IDE), with the preparation and review that brings [5].
Does your study need an FDA IDE?
It depends on your device's risk. A significant-risk device presents a potential for serious risk to subjects, for example as an implant, a life-supporting device, or a device of substantial importance in diagnosing or treating disease [5]. FDA's information sheet on significant and non-significant risk studies, issued January 2006, explains how sponsors and IRBs make the call [7].
Non-significant-risk studies take a lighter route. They are treated as having an approved IDE once an IRB approves them, provided you meet the abbreviated requirements, such as proper labeling and informed consent [5]. There is no FDA application, unless FDA notifies you that one is required [5].
Significant-risk studies need FDA's approval. A study can begin 30 days after FDA receives the IDE application, unless FDA notifies you that it may not begin, or sooner if FDA approves it by order [5]. FDA's fee schedule lists no fee for an IDE [6].
Can you use clinical data from outside the US?
Yes, if the study meets FDA's conditions. Under 21 CFR 812.28, FDA will accept data from a clinical investigation conducted outside the US to support an IDE, a 510(k), a De Novo request or a PMA [5]. The study must be well designed and well conducted, and three conditions apply:
- You provide a statement that the study followed good clinical practice, which includes ethics committee approval before it starts, continuing ethics review, and documented informed consent [5].
- You submit the supporting information the rule lists, which is shorter for non-significant-risk devices [5].
- FDA is able to validate the data through an onsite inspection or other means, if it decides to [5].
The requirement comes from a final rule published on February 21, 2018, which took effect on February 21, 2019 [8]. It applies to studies that enrolled their first subject on or after that date. For earlier studies outside the US, FDA applies its previous standard in 21 CFR 814.15 [8].
Many device studies already run outside the US. Of the 1,747 recent industry device studies, 56% had no US site [2]. South Korea hosted sites for 61 of them, India for 22, and Taiwan and Japan for 17 each [2]. If you hold a CE mark, our guide on using CE-mark clinical data for a 510(k) covers what transfers. For studies run in Korea, see what transfers from an MFDS licence.
Does your trial have to be registered on ClinicalTrials.gov?
Often, yes, and results reporting takes time and money. US law requires registration of an applicable device clinical trial [10]. That means an interventional study of an FDA-regulated device, other than a feasibility study, with a US site, a device made in and exported from the US, or an FDA IDE.
The deadlines are fixed. You must register within 21 calendar days of enrolling the first participant, and submit results within 1 year of the primary completion date [10].
Studies wholly outside the US may fall outside the rule. A study with no US site and no IDE, of a device made outside the US, does not meet that definition [10]. You may still need to register under your own country's rules.
Can FDA require more clinical study after clearance?
Yes. Under section 522 of the FD&C Act, FDA can order postmarket surveillance for a Class II or Class III device that meets any of four criteria [12]:
- Its failure would be reasonably likely to have serious adverse health consequences.
- It is intended to be implanted in the body for more than 1 year.
- It is intended to support or sustain life outside a user facility.
- It is expected to have significant use in children.
FDA may order prospective surveillance for up to 36 months, and longer only with your agreement [12]. A device whose maker fails to comply is considered misbranded [12]. A dental implant, for example, is a Class II device meant to stay in the body for years, so it meets the implant criterion. Budget for the possibility if your device fits any of the four.
How do you budget a device clinical study?
Work through these seven steps in order. Each one changes the number that follows.
- Confirm you need clinical data. Check the four scenarios above, then confirm with FDA in a Pre-Submission.
- Classify the study's risk. Significant risk means an FDA IDE; non-significant risk means IRB approval only.
- Fix the endpoints and sample size with a statistician. Enrollment is the biggest single cost driver. To sanity-check it, search ClinicalTrials.gov for completed interventional studies of devices like yours and compare their enrollment and duration.
- Choose countries and sites. Studies outside the US can support your submission under 21 CFR 812.28, if they meet its conditions.
- Estimate the duration. Add the enrollment period to the follow-up period your endpoints require. Around the study itself, allow up to 70 days for Pre-Submission feedback and 30 days after FDA receives an IDE [5, 9]. Recent industry device studies took a median 12.6 months to primary completion [2].
- Price each line. Include per-patient site payments, monitoring, data management, statistics, ethics or IRB review, insurance and device supply.
- Add a contingency for slow enrollment and protocol amendments, both of which add months and cost.
Comparable studies are the best check on your assumptions. Superagent's Clinical Trial Locator can help you find device studies like yours, and ClinicalTrials.gov is free to search directly. For ways to bring each line down, see our guide to reducing clinical trial costs.
Frequently asked questions
How much does a medical device clinical trial cost?
An HHS-funded study estimated $1.4 million for a feasibility study and $30.7 million for a pivotal trial of a novel high-risk device, in 2018 dollars. Most device studies are much smaller: recent industry studies enrolled a median of 56 patients, so their costs are usually far lower.
How much does a clinical trial cost per patient?
In the HHS-funded model for novel high-risk devices, a pivotal-study patient cost $54,332, a feasibility-study patient $34,059, and a post-approval-study patient $14,416, all in 2018 dollars. The figures came from Medidata Solutions data. Costs vary widely with the device and follow-up.
How many patients does a device clinical trial need?
It depends on your endpoints and statistics. Across 1,747 industry device studies completed from 2023 to 2025, the median enrolled 56 patients, and 44% enrolled fewer than 50. The HHS model's pivotal study for a novel high-risk device enrolled 565.
How long does a medical device clinical trial take?
Recent industry device studies took a median of 12.6 months from start to primary completion, and the middle half took 5.8 to 24.5 months. The HHS model's pivotal study for a novel high-risk device ran 56.9 months. Your endpoints set the follow-up period, which often decides the total.
Does a 510(k) need a clinical trial?
Usually not. In an FDA sample of 510(k)s, 14% included clinical data. FDA's 2023 draft guidance lists four situations where it may be needed, such as different indications or technology, or when testing alone cannot show substantial equivalence. A Pre-Submission is the way to confirm FDA's view before you plan one.
What is an IDE, and do I need one?
An investigational device exemption lets you use an unapproved device in a clinical study. Significant-risk studies need an FDA-approved IDE. Non-significant-risk studies are treated as having one once an IRB approves them, if you meet the abbreviated requirements. FDA's fee schedule lists no fee for an IDE.
How long does FDA take to review an IDE?
A significant-risk study can begin 30 days after FDA receives the IDE application, unless FDA tells you it may not begin. FDA can also approve the IDE by order sooner. FDA's user fee schedule lists no fee for an IDE application.
Can I use clinical data from studies in Korea or Europe?
Yes, if the study followed good clinical practice, you submit the supporting information 21 CFR 812.28 requires, and FDA can validate the data if it decides to. The rule covers IDEs, 510(k)s, De Novo requests and PMAs. More than half of recent industry device studies ran with no US site at all.
Is a Pre-Submission worth it before a clinical study?
Usually, yes. A Pre-Submission gets FDA's feedback on whether you need a study and on its design before you commit a budget. FDA's fee schedule lists no fee for it, so the main cost is your team's time to prepare.
Does my device trial have to be registered on ClinicalTrials.gov?
If it is an applicable device clinical trial, yes: register within 21 calendar days of the first enrollment, and post results within 1 year of primary completion. The rule covers controlled device studies other than feasibility studies with a US site, a US-made device or an FDA IDE.
What is the difference between a feasibility study and a pivotal study?
A feasibility study is a small early study that tests the device and study design. A pivotal study is the larger study that provides the main evidence for FDA. In the HHS model, the pivotal study cost about 22 times as much.
Are most device trials randomized?
No. Of 1,747 industry device studies completed from 2023 to 2025, 41% were randomized. The rest used other designs, such as single-arm studies. A Pre-Submission is the place to confirm which design FDA will accept. Randomization adds a control group, and with it more patients and cost.
References
- Sertkaya A, DeVries R, Jessup A, Beleche T. Estimated Cost of Developing a Therapeutic Complex Medical Device in the US. JAMA Network Open, 2022. Full text via PubMed Central.
- ClinicalTrials.gov. Data API. Industry-sponsored, completed interventional device studies with primary completion from 2023 to 2025. Queried September 25, 2026.
- FDA. Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices: Preliminary Regulatory Impact Analysis. Docket No. FDA-2013-N-0080.
- FDA. Recommendations for the Use of Clinical Data in Premarket Notification (510(k)) Submissions. Draft guidance issued September 7, 2023.
- eCFR. 21 CFR Part 812, Investigational Device Exemptions. Text current as of September 1, 2026.
- Federal Register. Medical Device User Fee Rates for Fiscal Year 2027, 91 FR 48134. Published July 30, 2026.
- FDA. Significant Risk and Nonsignificant Risk Medical Device Studies. Information sheet guidance, January 2006.
- Federal Register. Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices. Final rule published February 21, 2018; effective February 21, 2019.
- FDA. MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027 (MDUFA V commitment letter).
- eCFR. 42 CFR Part 11, Clinical Trials Registration and Results Information Submission. Accessed September 25, 2026.
- FDA. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. Final guidance, December 2025.
- eCFR. 21 CFR Part 822, Postmarket Surveillance. Accessed September 25, 2026.