A 2010 survey of more than 200 companies put the average cost of a moderate-risk 510(k) device at $31 million, from concept to clearance. A 2022 study funded by HHS put a novel high-risk therapeutic device at $54 million, or $522 million once failed projects and financing costs are counted.
Key takeaways
- A 2010 industry survey put the average 510(k) device at $31 million from concept to clearance, and a PMA device at $94 million, excluding reimbursement and sales costs.
- A 2022 HHS-funded study estimated $54 million to develop a novel therapeutic complex device, or $522 million counting failed projects and the cost of capital.
- In that study, FDA's own submission and review stage was 0.5% of the full cost. Nonclinical development was 85%.
- Multiplying the study's stage-by-stage success rates, only about 1 in 7 novel complex devices that enter development reach FDA approval.
- By our count, design problems caused 36% of 2025 FDA device recall events with a known cause. Software design alone caused 91.
How much does it cost to develop a medical device?
It depends on how new and how risky your device is. Two studies give the best public reference points, and they measure different things.
| Study | Device type | Estimated cost | What it covers |
|---|---|---|---|
| Stanford-led survey, 2010 | Moderate-risk 510(k) device | $31 million | Concept to clearance, excluding reimbursement and sales |
| Stanford-led survey, 2010 | Higher-risk PMA device | $94 million | Concept to approval, same exclusions |
| HHS-funded study, 2022 | Novel therapeutic complex device | $54 million | Mean development cost, excluding post-approval studies |
| HHS-funded study, 2022 | Novel therapeutic complex device | $522 million | Adds failed projects and the cost of capital |
Sources: the 2010 survey [1] and the 2022 study in JAMA Network Open [2].
Treat the 2010 figures as a rough guide. The survey drew on 204 companies, about 20% of public and venture-backed device makers, and industry groups including MDMA, NVCA and AdvaMed supported it [1]. It is also 16 years old. It still offers a useful ratio: the average 510(k) device cost about a third as much as the average PMA device [1].
The 2022 figures apply to a narrow group. They cover novel therapeutic complex devices on the Premarket Approval (PMA) route, not the typical Class II device [2]. Our founder path walks through the development stages in order.
Where does the money go?
Most of it goes into development and testing, long before FDA sees a file. In the HHS-funded study, nonclinical development took 85% of the full cost, and FDA's submission and review stage took 0.5% [2].
FDA's review is a small share of the cost. The evidence it requires is not. The 2010 survey counted $24 million of the $31 million 510(k) cost as FDA-dependent or related activities [1]. The two findings fit together. The review itself costs little, while the testing and studies FDA expects cost most.
Most projects never reach approval. The 2022 study measured how often a novel complex device moves from one stage to the next [2].
| Stage | Chance of reaching the next stage |
|---|---|
| Nonclinical work to feasibility study | 46.9% |
| Feasibility study to pivotal study | 48.0% |
| Pivotal study to PMA submission | 75.7% |
| PMA submission to approval | 80.5% |
Multiplied together, these give about 14%, or roughly 1 in 7 projects. Failed projects and the cost of capital are why the estimate rises from $54 million to $522 million [2].
Clinical studies are a major line for devices that need them. Our guide to medical device clinical trial costs breaks that budget down.
What does a 510(k) add to the budget?
For most devices, the 510(k) submission is a small part of development cost. FDA's fee is $28,653 from October 1, 2026, or $7,163 for a qualifying small business [4].
Most of the time goes into work before you submit. In the 2010 survey, companies reported an average of 31 months from their first contact with FDA to clearance of a 510(k) device [1]. FDA's review is a much shorter part of that path. By our count, the median 510(k) cleared in 2025 took 126 calendar days from FDA receipt to decision [3].
Our 510(k) cost guide covers the full submission budget: testing, preparation time, review time and the choices that lower each one.
What does it cost to get design wrong?
A recall. By our count of FDA's 2025 recall records, design problems caused 36% of recall events with a known cause: 255 of 718 [3].
| Root cause FDA recorded, 2025 | Recall events |
|---|---|
| Process control | 167 |
| Device design | 101 |
| Software design | 91 |
| Other design causes (process, packaging, labeling, components) | 63 |
| Sold without a required marketing application | 18 |
Source: we ran this count on September 24, 2026, covering all 945 recall events initiated in 2025, via openFDA [3]. Another 227 were still under investigation, so the percentage uses the 718 with a recorded cause.
Design controls are the cheaper fix. FDA's Quality Management System Regulation, 21 CFR Part 820, incorporates ISO 13485, including its design and development requirements [5]. Catching a design problem in verification avoids the recall, the correction and the lost sales that follow one. Our QMSR guide explains what the rule requires.
Study your device type's recalls before you design. FDA's records show what went wrong for similar devices. Complizen's Knowledge module gives direct access to FDA recall and adverse event records, so you can review them for your product code before design freeze.
Skipping FDA review is not a saving. In 2025, 18 recall events involved devices sold without a required marketing application [3].
How do you build your own development budget?
Published averages cannot tell you what your device will cost. These six steps get you to an estimate you can defend.
- Confirm your pathway. A 510(k), De Novo or PMA sets how much evidence you need. The free pathway finder shows which route fits your device.
- List your required tests. Your product code points to FDA's recognized standards and any special controls. Our guide to FDA medical device classification shows how to find them, so you can ask laboratories to quote against that list.
- Decide whether you need clinical data. Most 510(k)s do not include it. In FDA's own random sample of 510(k)s submitted in fiscal year 2009, 14% included any clinical data and 9% included a pivotal study of more than 30 people [9]. If you do need it, it is likely to become one of your largest lines, so confirm the question early in a Pre-Submission.
- Add FDA's fixed costs. Include the 510(k) fee, the annual establishment registration fee and, for a manufacturer outside the US, a US Agent [4, 6].
- Add time. Budget your team's months of work, plus at least one round of FDA questions during review.
- Adjust for risk. A novel device has a real chance of failing a stage, and the 2022 study's success rates show how much that raises the cost of reaching the market [2].
What does the method look like for a real device?
Here are the six steps applied to a root-form dental implant, product code DZE, a common Class II export from Korea. Every row comes from FDA's records.
| Step | Root-form dental implant (DZE) |
|---|---|
| 1. Pathway | 510(k), Class II, with a special controls guidance [10] |
| 2. Required tests | 12 recognized standards, including ISO 14801 for dynamic loading and ISO 7405 for dental biocompatibility [10] |
| 3. Clinical data | Check the special controls guidance first; across all 510(k)s, FDA's sample found clinical data in 14% [9] |
| 4. FDA fixed costs | $28,653 fee, or $7,163 for a small business, plus $13,785 a year for registration and a US Agent if you are based outside the US [4, 6] |
| 5. Time | 31 cleared in 2025, with a median of 184 calendar days from FDA receipt to decision [3] |
| 6. Risk | 11 recall events from 2020 to 2025; none with a recorded cause was a design problem [3] |
Source: FDA's classification entry for DZE [10], and our count of FDA's 510(k) and recall records via openFDA [3].
The last row changes where a dental implant maker should spend. In FDA's records, recent dental implant recalls came from process control, packaging and labeling changes, and manufacturing conditions, not from design [3]. So the budget should cover process validation and packaging controls as seriously as design verification. The numbers are small, so treat them as a signal rather than a rule.
If you manufacture in Korea, our guide on whether an MFDS licence helps with FDA clearance covers what transfers from a Korean file.
How can you lower development cost?
Four choices lower cost without lowering the evidence FDA expects.
Pick the lightest pathway that fits. The 2010 survey found PMA devices cost about three times as much as 510(k) devices [1]. If your device has no predicate but is low to moderate risk, a De Novo request may fit instead of a PMA [7, 8]. Our guides to the De Novo pathway and PMA explain what each involves.
Ask FDA before you test. A Pre-Submission gets FDA's feedback on your plan before you pay for studies. FDA's fee schedule lists no fee for it [4]. Our Q-Submission guide covers how to prepare one.
Choose a strong predicate early. A defensible predicate narrows the testing FDA expects. Complizen's Superagent includes workflows for finding a defensible predicate and for checking MAUDE adverse event data on it.
Use the small business fee if you qualify. It cuts the 510(k) fee from $28,653 to $7,163 for a business with gross receipts of $100 million or less [4].
How are costs different for an established manufacturer?
If you already sell the device outside the US, much of the development is done. Your FDA budget then centres on closing gaps rather than starting over.
The gaps usually sit in four places:
- Testing to FDA-recognized standards. Your product code sets which standards apply, and some existing test reports may already cover them.
- Design documentation that meets FDA's quality rule. 21 CFR Part 820 applies to most devices [5].
- The 510(k) itself. The fee, preparation and review time are in our 510(k) cost guide.
- A US Agent. Every foreign establishment must name one under 21 CFR 807.40 [6].
Budget more time if you file from Korea or Taiwan. By our count, Traditional 510(k)s cleared in 2025 took a median 170 calendar days for Korean applicants and 197 for Taiwanese applicants, against 134 for US applicants [3]. Calendar time includes the days a file waits while the applicant answers FDA, so fast, complete answers are the part you control.
Some evidence can transfer from approvals you already hold. Our guide on what transfers from a CE mark to a 510(k) covers the most common case, and our international path covers each priority market.
Frequently asked questions
How much does it cost to develop a medical device?
A 2010 industry survey put a moderate-risk 510(k) device at about $31 million from concept to clearance, and a PMA device at $94 million. A 2022 HHS-funded study put a novel high-risk therapeutic device at $54 million, or $522 million counting failures and financing.
How much does a Class II device cost to bring to market?
Most Class II devices go through a 510(k). The 2010 survey put the average 510(k) device at $31 million from concept to clearance, excluding reimbursement and sales. The survey is old and industry-supported, so treat it as a rough guide rather than a budget.
How much does a Class III device cost to develop?
The 2010 survey put a PMA device at about $94 million. The 2022 HHS-funded study estimated $54 million for a novel therapeutic complex device, rising to $522 million once failed projects and the cost of capital are included in the estimate.
What share of development cost is FDA review?
Very little. In the 2022 HHS-funded study, FDA's submission and review stage was 0.5% of the full cost. Most spending goes into the testing and studies FDA expects, which the 2010 survey counted as FDA-dependent or related activities. So budget mainly for evidence, not for the review itself.
How many medical devices fail during development?
Most novel complex devices do not reach approval. The 2022 HHS-funded study found stage-to-stage success rates of 46.9%, 48.0%, 75.7% and 80.5%. Multiplied together, only about 1 in 7 projects that enter development reach FDA approval. These rates apply to novel therapeutic complex devices, not to typical 510(k) devices.
What is the biggest cost in medical device development?
For novel complex devices, nonclinical development is the largest share: 85% of the full cost in the 2022 HHS-funded study, once failures and the cost of capital are counted. Clinical studies are also a major cost for devices that need them.
How much does the 510(k) submission itself cost?
FDA's 510(k) user fee is $28,653 from October 1, 2026, or $7,163 for a qualifying small business. Testing, preparation and your team's time come on top, and they depend on your device, your predicate and how complete your file is.
What causes most medical device recalls?
In 2025, process control was the most common recorded cause, at 167 recall events. By our count of FDA's records, design problems caused 36% of recall events with a known cause, and software design alone caused 91 of them. Another 227 events were still under investigation.
Are published development cost estimates reliable?
Treat them as reference points, not budgets. The 2010 survey drew on 204 companies and was supported by industry groups, and the 2022 study models one narrow group of novel devices. Build your own estimate from your pathway, predicate and test plan.
How long does medical device development take?
In the 2010 survey, companies reported an average of 31 months from first contact with FDA to clearance of a 510(k) device. FDA's review is a shorter part of that path: by our count, the median 510(k) in 2025 took 126 calendar days.
Does it cost less to bring an existing device to FDA?
Often, because much of the development is already done. Your FDA budget then covers testing to FDA-recognized standards, design documentation under FDA's quality rule, the 510(k) itself and a US Agent. Some evidence from existing approvals can transfer, so start by checking which test reports already cover FDA-recognized standards.
Does a 510(k) need clinical data?
Usually not. In FDA's own random sample of 510(k)s submitted in fiscal year 2009, 14% included any clinical data and 9% included a pivotal study of more than 30 people. The sample is old, so confirm what your device needs in a Pre-Submission before you budget for a study.
References
- Makower J, Meer A, Denend L. FDA Impact on U.S. Medical Technology Innovation: A Survey of Over 200 Medical Technology Companies. November 2010.
- 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.
- openFDA. Device API: recall and 510(k) endpoints. 2025 records pulled September 24, 2026.
- Federal Register. Medical Device User Fee Rates for Fiscal Year 2027, 91 FR 48134. Published July 30, 2026.
- eCFR. 21 CFR Part 820, Quality Management System Regulation. Accessed September 24, 2026.
- eCFR. 21 CFR 807.40, Registration and listing of foreign establishments. Accessed September 24, 2026.
- FDA. De Novo Classification Request. Content current as of September 30, 2025.
- FDA. Premarket Approval (PMA). Content current as of May 16, 2019.
- FDA. Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices: Preliminary Regulatory Impact Analysis. Docket No. FDA-2013-N-0080. Sample of submissions from fiscal year 2009.
- FDA. Product Classification Database entry for product code DZE. Checked September 24, 2026.