The short answer. Most medical devices reach the US market without an FDA “approval”. FDA clears a 510(k) for a device that is substantially equivalent to one already sold, grants a De Novo request for a new low to moderate risk device with no predicate, and approves a PMA for a high risk Class III device. Most Class I devices are exempt from the 510(k). A 510(k) received in FY2025 took 141 calendar days on average to a decision, and the FY2027 FDA fee is $28,653 ($7,163 for a qualified small business). The engineering comes first and costs more: 4,000 to 6,000 hours from an idea to a production-ready design in OVA proposals.
Cleared, granted or approved: the three pathways
Cleared, granted and approved are not interchangeable. Only a PMA is an FDA approval. Under 21 CFR 807.97, a 510(k) clearance “does not in any way denote official approval”, and presenting it as one is misbranding. In calendar 2025 FDA cleared 3,198 510(k)s, granted 27 De Novo requests and approved 40 original PMAs (OVA counts from FDA databases).
| Pathway | Used for | FDA decision | FDA review goal | FY2027 fee (small business) |
|---|---|---|---|---|
| 510(k) | Devices with a legally marketed predicate | Cleared | 90 FDA days (95% of files) | $28,653 ($7,163) |
| De Novo | New low to moderate risk devices, no predicate | Granted | 150 FDA days (90% in FY2027) | $191,020 ($47,755) |
| PMA | Class III, the highest risk | Approved | 180 FDA days (90%) without an advisory panel | $636,732 ($159,183) |
| Exempt | Most Class I, some Class II | None needed | None | No submission fee |
510(k). You show substantial equivalence to a legally marketed predicate: the same intended use, and the same technology or differences that raise no new questions of safety and effectiveness. Evidence can include bench, EMC, software and biocompatibility data, and clinical data when needed.
De Novo. For a new type of device with no predicate, when general and special controls are enough. You file directly or after a 510(k) comes back not substantially equivalent. A grant creates a new classification regulation, and your device can become a predicate.
PMA. For Class III devices, where controls alone cannot assure safety and effectiveness. Approval needs valid scientific evidence, usually including clinical investigations.
Exempt devices
In FDA’s classification data (openFDA, updated October 12, 2026), 2,155 of 2,403 Class I product codes (about 90%) and 484 of 3,645 Class II codes (about 13%) are 510(k) exempt. Registration, listing, labeling, adverse event reporting and the quality system rules still apply unless the regulation says otherwise. A new intended use or a different fundamental technology ends the exemption (21 CFR 862.9 to 892.9).
How to find your device class and product code
The class follows from the intended use, the indications for use and the risk. FDA has classified about 1,700 generic device types in 16 specialty panels.
- Write the intended use and indications for use in plain sentences. The class depends on the claims, not only the hardware.
- Search FDA’s Product Classification Database by device name. Each entry gives a three-letter product code, the class, the regulation in 21 CFR Parts 862 to 892 and any exemption.
- Search the 510(k), De Novo and PMA databases by that product code to find candidate predicates.
- Still unclear? Ask FDA. A 513(g) request for classification information costs $8,596 in FY2027 ($4,298 for a small business), and FDA intends to answer within 60 days. A Pre-Submission is the other route.
Step by step: from idea to clearance
A typical 510(k) program for a powered Class II device. De Novo and PMA programs follow the same order with more evidence.
1. Set the intended use and the pathway
Decide the claims, class, predicate and pathway before detailed design. That is regulatory strategy, owned by you and your regulatory consultant, and the claims become design inputs.
2. Put design controls in place
Since February 2, 2026, the Quality Management System Regulation (QMSR, 21 CFR Part 820) incorporates ISO 13485:2016. Design controls under its clause 7.3 apply to Class II and III devices and to Class I devices automated with software (21 CFR 820.10(c)). The design history file now lives in the design and development file.
3. Start the risk file with the first concept
The QMSR builds risk management into the whole quality system but does not incorporate ISO 14971. In four OVA Class II and sterile proposals, documentation work (design controls, ISO 14971 risk management, IEC 62304 software documentation, IEC 60601 test preparation) was 15% to 31% of the estimated hours. In our experience it costs more when written at the end.
4. Verify, validate and test
Most of the evidence comes from here:
- Electrical safety and EMC: IEC 60601-1 for basic safety, and IEC 60601-1-2 for EMC (FDA EMC guidance, June 2022).
- Biocompatibility for materials that touch the body (FDA ISO 10993-1 guidance, September 2023).
- Software documentation at the Basic or Enhanced level (FDA guidance, June 2023); Enhanced when a software failure could present a probable risk of death or serious injury.
- Human factors (guidance reissued August 2026).
- Cybersecurity for connected devices (see Section 524B).
Book outside labs early: a test report you still have to order adds weeks.
5. Ask FDA first: the Pre-Submission
A Pre-Submission asks FDA for written feedback on your test plan, predicate or study, with an optional meeting (Q-Submission guidance, May 2025). FDA’s goal is feedback within 70 days or five days before the meeting, whichever comes first. In FY2025 CDRH received 4,431 of them, more than its 3,966 510(k)s, and met the goal 97.5% of the time. The FY2027 fee table lists no fee for it.
A clinical study of a significant risk device needs an FDA-approved Investigational Device Exemption (IDE) before it starts; a nonsignificant risk study needs IRB approval (21 CFR 812.2 and 812.20).
6. Submit through eSTAR
Since October 1, 2023, every 510(k) must be an eSTAR, and since October 1, 2025, every De Novo too. It is usually sent through the CDRH Portal, with the fee. Get small business status first: FDA aims to decide within 60 days and does not refund the difference.
7. Review: screening, questions, decision
Screening takes up to 15 days. By day 60 FDA responds; in about two of three 510(k)s it asks for more information, which stops the FDA clock until you answer (within 180 days). FY2025 files averaged 1.69 review cycles. FDA does not typically inspect before a 510(k) clearance.
8. After clearance: registration, listing, QMSR, postmarket
- Register and list within 30 days of starting operations, then every year between October 1 and December 31 (21 CFR 807.22). FY2027 registration costs $13,785, with no small business rate.
- Run the QMSR. FDA can inspect at any time, including management review and audit reports. An ISO 13485 certificate does not exempt you.
- Report problems: deaths, serious injuries and malfunctions that could cause them within 30 calendar days, or 5 work days when remedial action is needed (21 CFR 803.50, 803.53); corrections or removals that reduce a risk to health within 10 working days (806.10).
- Check every change. One that could significantly affect safety or effectiveness, or a new intended use, needs a new 510(k) unless a cleared change control plan covers it (21 CFR 807.81).
How long it takes: FDA days vs calendar days
FDA’s goals count FDA days, which stop while FDA waits for your answers. Plan in calendar days.
| Pathway | FDA goal | Average total days to a decision (FDA plus company time) |
|---|---|---|
| 510(k) | 90 FDA days for 95% | 141 for FY2025 submissions; median of 126 from receipt to clearance in calendar 2025 |
| De Novo | 150 FDA days for 90% (FY2027 goal) | 270, 248 and 278 for requests received in FY2023, FY2024 and FY2025 |
| PMA without an advisory panel | 180 FDA days for 90% | 298 and 320 for submissions received in FY2023 and FY2024 |
FDA meets its goals: 97.9% of FY2025 510(k)s were decided within 90 FDA days. The rest is the company’s time: 66 of the 141 days. Finished testing shortens it. A Special 510(k), for a change to your own cleared device, took a median of 30 days in 2025.
Before all this comes the engineering: for a battery-powered Class II device that reads body signals over Bluetooth, our cost calculator estimates 6 to 12 months from idea to production-ready design.
What it costs: FDA fees and engineering hours
| FDA fee, FY2027 | Standard | Small business |
|---|---|---|
| 510(k) | $28,653 | $7,163 |
| De Novo request | $191,020 | $47,755 |
| PMA (original) | $636,732 | $159,183 |
| 513(g) request for classification information | $8,596 | $4,298 |
| Annual establishment registration | $13,785 | no reduced rate |
A small business has gross receipts or sales of $100 million or less, affiliates included; at $30 million or less, a first PMA fee can be waived. A 510(k) reviewed by an FDA-accredited third party has no FDA fee; the reviewer charges its own.
Engineering is the larger cost. Hours from OVA proposals, at our $125 rate:
| Starting point and goal | Engineering hours | At $125 per hour |
|---|---|---|
| Concept or proof of concept to 3 to 10 working prototypes | 1,000 to 2,500 | $125,000 to $312,500 |
| Idea or early prototype to a production-ready design or pilot batch | 4,000 to 6,000 | $500,000 to $750,000 |
| Large systems such as ventilators or glucose monitors | 10,000 to 30,000 | $1.25 million to $3.75 million |
Not included: components, outside labs, FDA fees, clinical studies and tooling. To price your device phase by phase, use the cost calculator.
Cybersecurity for connected devices: Section 524B
Since March 29, 2023, Section 524B of the FD&C Act requires every 510(k), De Novo and PMA for a cyber device to include a plan to monitor and address postmarket vulnerabilities, processes for updates and patches, and a software bill of materials (SBOM). Since October 1, 2023, FDA may refuse to accept a submission without them.
A cyber device includes software or firmware, can connect to the internet, and could be vulnerable to threats. FDA counts Wi-Fi, Bluetooth, cellular and USB as connections, so almost every connected wearable qualifies. The current guidance is dated February 3, 2026. Start the threat model and SBOM when you choose the radio and update path.
Common mistakes that cost months
- Calling a cleared device “FDA approved”. It is misbranding under 21 CFR 807.97.
- Choosing the pathway after design freeze. A new claim or missing predicate can turn a 510(k) into a De Novo: almost seven times the fee, close to twice the time.
- Submitting before testing is done. Company time answering questions averaged 66 of the 141 days for FY2025 510(k)s.
- Treating eSTAR as paperwork. 7.2% of 510(k)s received in FY2025 were refused or failed screening on the first cycle.
- Adding Bluetooth late. The radio makes it a cyber device, with an SBOM and patch process due in the submission.
- Applying for small business status too late. Allow 60 days before the fee is due.
What OVA does here, and where our responsibility ends
OVA Solutions is a medical device engineering group: 62 engineers, 220 devices developed, $125 per engineering hour, working under an ISO 13485:2016 certified quality system through Canyon Medical. We design electronics, firmware and mechanics, and we prepare the engineering side of a submission: design history file inputs, risk management inputs and verification reports. We are not a regulatory consultant and not a contract manufacturer. The regulatory strategy and the submission stay with you or your regulatory consultant. To talk through your device, book a 30-minute call.
Questions
Is FDA clearance the same as FDA approval?
No. FDA approves PMAs, grants De Novo requests and clears 510(k)s. All three let you sell in the US, but only a PMA device is “FDA approved”. Calling a clearance an approval is misbranding (21 CFR 807.97).
How long does it take to get a medical device through FDA?
The review averaged 141 calendar days for a FY2025 510(k), 248 to 278 for a De Novo and 298 to 320 for a PMA without an advisory panel. Before it comes the engineering: 6 to 12 months from idea to production-ready design for a Bluetooth Class II device in our calculator.
How much does FDA clearance cost?
The FY2027 510(k) fee is $28,653 ($7,163 for a small business), plus $13,785 a year for registration. Engineering costs more: 4,000 to 6,000 hours from idea to production-ready design in OVA proposals, $500,000 to $750,000 at $125 per hour, before labs and clinical work.
Does my device need a clinical trial?
Not always. In its 510(k) Program guidance (July 2014), FDA said it requested clinical data for less than 10 percent of 510(k)s. PMAs usually include clinical investigations. A significant risk study needs an FDA-approved IDE first. Ask in a Pre-Submission.
Does a wellness wearable need FDA clearance?
Not if it is intended only for general wellness, such as fitness, stress or sleep management, and presents low risk (FDA General Wellness guidance, January 2026). Disease claims take it outside that policy. At least 7 of 70 prospects in our 2025 to 2026 call sample planned to launch as wellness first and seek clearance later.
Who submits the 510(k) if another company builds the device?
You do. FDA says the specification developer, who has the device made under contract, submits the 510(k), not the contract manufacturer. Engineers and consultants prepare parts; the submission is yours.
Related pages
- 510(k) review times in 2026
- De Novo review time, grant rate and FY2027 fee
- FDA medical device user fees for FY2027
- FDA QMSR 2026: what changed from the QSR
- FDA cybersecurity requirements: Section 524B
- Medical device development in hours: 2026 benchmark
- What medical device development costs
- Medical device development cost calculator
Sources
- FDA: Premarket Notification 510(k) and How to Prepare a Special 510(k)
- FDA: De Novo Classification Request
- FDA: Premarket Approval (PMA)
- 21 CFR 807.97: Misbranding by reference to premarket notification
- FDA: Classify Your Medical Device and Class I and Class II Device Exemptions
- openFDA: device classification and PMA endpoints (data updated October 12, 2026)
- FDA guidance: Procedures for Section 513(g) Requests for Information (August 2024)
- 21 CFR 820.10: Requirements for a quality management system
- FDA guidance: Electromagnetic Compatibility (EMC) of Medical Devices (June 2022)
- FDA guidance: Use of International Standard ISO 10993-1 (September 2023)
- FDA guidance: Content of Premarket Submissions for Device Software Functions (June 2023)
- FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices (August 2026)
- FDA guidance: The Q-Submission Program (May 2025)
- 21 CFR Part 812: Investigational Device Exemptions
- FDA: MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027
- FDA: Quarterly Update on Medical Device Performance Goals, MDUFA V, actions through June 30, 2026
- Federal Register: Medical Device User Fee Rates for Fiscal Year 2027 (July 30, 2026)
- FDA: Device Registration and Listing and 21 CFR 807.22
- 21 CFR 803.50, 803.53 and 806.10: adverse event, correction and removal reports
- 21 CFR 807.81 and FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017)
- FDA guidance: Cybersecurity in Medical Devices (February 3, 2026)
- FDA guidance: The 510(k) Program: Evaluating Substantial Equivalence (July 2014)
- FDA guidance: General Wellness: Policy for Low Risk Devices (January 2026)
- OVA Solutions reference pages, fact-checked October 8 to 10, 2026: 510(k) review times, De Novo, user fees, QMSR, Section 524B, hours benchmark
Rewritten and fact-checked against FDA, eCFR and Federal Register sources on October 22, 2026.
More on this topic: Regulatory & Quality