FDA Clearance Costs in 2027: What Health Tech Should Budget

In fiscal 2027 a 510(k) costs $28,653 in FDA user fees, or $7,163 for a qualifying small business.¹ Testing, a quality system, outside help and sometimes a clinical study can cost several times more than the fee, so budget the whole path and put the clearance date in your runway model.

Picture the board meeting. A health tech founder puts up the runway slide, someone asks where FDA is in it, and the founder points to one line: $7,163. Everybody nods. That is the moment I would want to poke a hole in it, because the user fee is the smallest number on the whole path. I work with founders across the four industries I go real deep in: technology (AI and SaaS), healthcare and biotech, pharma, and pharmacy, and this piece is for the health tech and biotech ones. By the end you will be able to say how many months of cash your clearance uses and which date you are betting on. I am not a regulatory advisor or a lawyer, so talk to your regulatory counsel about which pathway your product needs.

What does a 510(k) cost in fiscal 2027?

The fee is $28,653, or $7,163 for a qualifying small business, and it is the easy line because FDA publishes it. A 510(k) is the premarket notification a company submits to market a device that does not need a premarket approval application, unless the device is exempt.² The fiscal 2027 rates come from the Federal Register notice FDA published on July 30, 2026. They run from October 1, 2026 through September 30, 2027 and match FDA's own fee page.¹³

The 510(k), De Novo, PMA and 513(g) fees each rose about 9.9% from fiscal 2026, and the annual establishment registration fee rose about 20.7%, from $11,423 to $13,785. Those percentages are my arithmetic from the two Federal Register notices.¹⁴ Put the registration fee in the plan as a standing line, because it has no small business reduction and it comes back every year.¹

Pay before you send. FDA says an application without full payment is treated as incomplete, so review does not start.⁵ Its refuse to accept policy says the acceptance review begins only for a 510(k) whose fee has been paid and whose electronic copy is valid, and it should be finished within 15 calendar days.⁶ Fees reset every October 1, so near that line ask counsel which year's rate applies.

How much do I save with small business status?

If you qualify, ask for the discount before you file. On a 510(k) the saving is $28,653 minus $7,163, which is $21,490. On a De Novo it is $191,020 minus $47,755, or $143,265, and on a PMA it is $636,732 minus $159,183, or $477,549.

The test is gross receipts or sales of no more than $100 million for your most recent tax year, counting your affiliates, and the fiscal 2027 notice leaves that threshold unchanged.⁴¹ The status is not automatic and it does not last. It expires every September 30, so you ask again each fiscal year, and FDA's page names the MDUFA Small Business Request Form 3602N, filed through the CDRH Portal.⁷ The fiscal 2026 notice asked small businesses to submit their qualification documents at least 60 days before a submission.⁴ I would put that on the calendar the day you pick a filing date, and confirm the fiscal 2027 lead time with counsel.

What does clearance cost beyond the user fee?

Here is how I think about it, the way I would explain it over coffee. The user fee is a published number, so it is the easy line. The money is in the work you do before FDA ever sees the file. I make a punch list of 4 lines to price, in the order most budgets feel them:

1. Testing. The bench, safety and software work that supports your claims.
2. A quality system. The documented way you design, build and control the product.
3. Outside regulatory help. The consultants and counsel who prepare and review the submission.
4. Clinical evidence, if FDA asks for it. The studies that can dwarf the other three.

Testing is the line I would poke a hole in first if a budget skipped it. Robert Packard of Medical Device Academy, a regulatory consultancy, writes that "The testing cost is the most significant cost, but I think the average is around $100K" for typical devices, and software and implantable devices may differ.⁸ His page itemizes biocompatibility at $13,000 to more than $100,000 and electrical safety and EMC testing at $50,000 to $60,000. It is one consultancy's view, so I carry $100,000 as a placeholder until a real quote replaces it.

The quality system is the one founders treat as paperwork, and it is not. FDA's Quality Management System Regulation took effect on February 2, 2026 and incorporates the international standard ISO 13485:2016 by reference.⁹ A practitioner guide from MedDeviceGuide estimates initial ISO 13485 certification at $22,000 to $83,000 for a company with fewer than 50 employees at a single site, and 6 to 12 months if you have no quality system yet.¹⁰ Six to 12 months of work is also 6 to 12 months of burn, so I want that time on the calendar early. Certification is a separate step from meeting the rule, so ask counsel which parts the rule requires of you.

Outside help is the cheap part and clinical evidence is the scary part. The same consultancy listed $3,500 for pre-submission preparation and $17,500 for 510(k) preparation, as of July 2023, which is old enough that I would ask for current quotes.⁸ On clinical evidence, MedDeviceGuide, a vendor guide, puts early feasibility studies at $300,000 to $1.5 million, pivotal studies at $2 million to $20 million or more and the cost per enrolled patient at $14,000 to $50,000 or more.¹¹ Medical Device Academy gives a lower range, $250,000 to $2.5 million, when studies are required.⁸ Whether you need a study at all is a regulatory question, so counsel answers it before your budget does.

The one large survey I found is old, so I would not budget from it, but it is food for thought. In 2010 a Stanford Biodesign and MDMA survey of more than 200 companies reported that the average total cost to bring a 510(k) product from concept to clearance was "approximately $31 million, with $24 million spent on FDA dependent and/or related activities."¹² Trade press put the FDA-related share at about 77%.¹³ Read it as a reminder that the user fee is a rounding error in the total, not as a price.

Do I even need clearance under the 2026 wellness and CDS guidance?

That is the cheapest question on this page, so ask it first. FDA published revised final guidance on general wellness products and on clinical decision support (CDS) software on January 6, 2026, according to the law firm King & Spalding.¹⁴ Gardner Law, a digital health firm, reads the changes as a more targeted refinement than a blanket loosening.¹⁵ For a health tech founder the line that matters is in the wellness guidance: "Products are not general wellness products when they are intended to measure, estimate, or report physiologic values for medical or clinical purposes."¹⁶ On decision support, FDA says its existing digital health policies still apply to software functions that meet the device definition,¹⁷ and it uses the IMDRF definition of software as a medical device.¹⁸

So a wellness tool, decision support that stays outside the device definition and a device are three different budgets, and which one you are turns on intended use and the claims you make. That is a call for your regulatory counsel, not for me and not for a spreadsheet. If the answer is device, three more pieces of FDA's pathway belong in the plan. The De Novo request is the route for novel devices with no legally marketed predicate.¹⁹ FDA's cybersecurity premarket guidance addresses the section 524B recommendations for cyber devices, so get that documentation priced.²⁰ And the voluntary Breakthrough Devices Program is aimed at speeding up development, assessment and review for certain devices that treat or diagnose life-threatening or irreversibly debilitating conditions.²¹

How do I budget FDA clearance inside my runway?

I learned to respect a regulator's calendar the hard way. I helped build Integrity Rx, a fertility pharmacy, from concept to roughly $50 million in about 4.5 years, and it took about 40 state permits. A permit date is not a footnote. It decides when your first dollar of revenue shows up, and FDA clearance works the same way for a device company.

Let me walk through it back of the napkin, the way I would on a call with a founder. These are illustrative numbers, not a client. A health tech company has $2,700,000 of cash and a monthly burn of $180,000, so it has 15 months of runway. It plans a 510(k) for a software device and qualifies for small business fees. The fee is $7,163 and the annual establishment registration is $13,785. It budgets the consultancy's $100,000 of testing as a placeholder, $21,000 for pre-submission and 510(k) preparation ($3,500 plus $17,500), and $22,000 to $83,000 for the quality system. That adds up to $163,948 on the low end and $224,948 on the high end, with no clinical study.

Now read it the way a board would, because this is the why behind the number. The low case is 0.91 months of burn and the high case is 1.25 months. If FDA asks for a clinical study at the low end of the consultancy's range, $250,000, the totals become $413,948 and $474,948, or 2.30 and 2.64 months of burn. The user fee, $7,163, is only 4.4% of the low non-clinical total. At standard rates it would be $28,653, or 15.5% of the $185,438 total. The line to watch is time. One extra month of review at $180,000 of burn costs more than the entire low non-clinical budget, and more than 25 times the small business fee. I tell founders that revenue is just a reduction in total burn, so a clearance date that slips is burn that nothing offsets.

That is why I put the clearance date in the model as a range, not a point. FDA's performance goal is a decision on 95% of 510(k) submissions within 90 FDA Days, and FDA Days are the calendar days between receipt and a MDUFA decision.²²²³ FDA's own performance report to Congress says the FY 2024 510(k) shared outcome goal was missed,²⁴ and a lawyer quoted by MedTech Dive about the FDA staffing cuts said "You're adding months if not years to the overall timeline of getting products to market."²⁵ That is one attorney's opinion, not data, but it is a risk I would rather show a board on a slide than explain after the fact. Show the best case at 90 days, a likely case and the date a longer review pushes first revenue to, with the cash you would still have in each.

Two accounting notes finish the budget. KPMG's handbook reproduces ASC 730-10-25-1, which says research and development costs are charged to expense when incurred.²⁶ It does not say whether an FDA user fee is research and development, so decide the classification with your accountant and tax partner before the first invoice lands, and your first P&L with these costs will not be a surprise. And put the payments in the 13 week cash flow forecast, where they land by date, as I describe in how to build a 13 week cash flow forecast. When an investor asks about your regulatory plan in diligence, the budget and the dated range are what they want to see, and I walk through that checklist in fundraising due diligence.

Has an FDA delay ever hit a public company's numbers?

Yes, though the facts are narrower than a refusal. As Benzinga reported on August 3, 2023, Outset Medical's chief executive said the company would file a 510(k) for TabloCart with Prefiltration and "pause distribution of the product until a 510(k) clearance has been granted," after a Warning Letter dated July 6, 2023.²⁷ The company guided to the low end of its $144 million to $150 million revenue range for 2023, and the shares fell 9.76% that day to $17.47.²⁷ A news report is a secondary source, so the company's SEC filing is the better one to cite.

My take is that the lesson is about dates, not fees. Outset's problem was not a $28,653 fee. It was a clearance date that determined when a product could ship, and the revenue guidance moved with it. That is why I tell founders to give the date an owner. Your runway model needs the same line, with a date, a range and one person who answers for it.

If you run a biotech, pharma, pharmacy or AI company, what changes?

A 510(k) is a device pathway. A drug or a biologic follows a different pathway with a different fee schedule that this article does not cover, so ask your regulatory counsel which one applies. For health tech and AI companies the question is usually whether your software is a device at all, which is the wellness and CDS question above.

The accounting habit carries across all four. At High Rock Accounting I was the sole accountant on a clinical-stage biopharmaceutical client's month-end close, and I owned its preclinical, clinical, manufacturing and general accruals through its Nasdaq IPO. Regulatory and clinical costs were estimates there too, and the habit I took from it is simple: ask what work has been done and what has not been billed yet. A device company accruing testing and consultant work needs the same habit, and it is the why behind the number when a board asks why spend moved. I explain the cash side in how to calculate runway.

If you only do 4 things after reading this, do these:

1. Replace the placeholders. Get real quotes for testing, the quality system and outside help.
2. Model the date as a range. Best case, likely case and slipped case, each with the cash left.
3. Ask counsel 3 questions. Which pathway, whether you qualify for small business fees and whether FDA will want clinical evidence.
4. Put the payments in the 13 week forecast. By date, so nothing lands as a surprise.