mdi Consultants, Inc510(k) clearance — guaranteed
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510(k) clearance — guaranteed
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One of the main way to bring a device to the US marketplace is to obtain FDA “clearance” via the 510(k) route. In order to do obtain a 510(k) clearance you need to demonstrate that your device is substantial equivalence to a legally marketed predicate device.
mdi Consultants provides expert guidance through every stage of the 510(k) process—helping you reduce risk, avoid delays, and achieve faster FDA clearance. mdi has successfully prepared and submitted over 5000 applications thru the FDA 510(k) process.
A 510(k) is a premarket submission to the U.S. Food and Drug Administration required for most Class II medical devices. It demonstrates that your device is safe and effective by comparing it to an existing, legally marketed device (predicate). Remember, you received from the FDA a “clearance” to market not an approval.
mdi Consultants offers end-to-end support tailored to your product and regulatory pathway:
Alan Schwartz left the FDA in 1978 to start MDI. That first-hand regulatory experience — knowing how FDA investigators think and what they look for — is embedded in every submission MDI prepares.
MDI does not charge hourly. Every engagement has a defined scope and a total project cost agreed before work begins. No scope creep, no surprise invoices, no “that wasn’t included.”
MDI staff averages 13 years of tenure at the firm. You are not assigned to a junior consultant who will learn regulatory affairs on your project and your budget.
FDA 510(k) cleared but also need CE marking, Health Canada approval, or MDSAP? MDI handles all three — no need to manage multiple consultants across jurisdictions.
Twelve retainer relationships have lasted more than ten years. Companies don’t stay with a consulting firm for a decade unless the work is consistently excellent and the relationship genuinely serves them.
Some firms provide guidance and let clients do the writing. MDI’s team prepares and compiles the complete 510(k) — all 21 sections — and manages all FDA correspondence through clearance.
A 510(k) premarket notification is required when you want to market a Class II medical device in the United States and your device has not received a previous FDA exemption. The 510(k) process demonstrates that your device is “substantially equivalent” to a legally marketed predicate device already on the U.S. market. You will also need a new 510(k) if you make a significant change to an already-cleared device that could affect its safety or effectiveness. The standard 510(k) FDA user fee for fiscal year 2026 is $26,067, or $6,517 for qualifying small businesses.
A 510(k) is used for Class II moderate-risk devices and requires demonstrating substantial equivalence to a predicate — the most common pathway, with FDA review typically taking 3–6 months.
A De Novo Classification Request is used when a novel, low-to-moderate risk device has no predicate, with a 2026 FDA fee of $173,782.
A PMA (Premarket Approval) is required for Class III highest-risk devices such as implantable pacemakers; it requires clinical evidence of safety and effectiveness and carries a 2026 standard fee of $579,272.
Choosing the wrong pathway can cost 6–12 months. mdi identifies the correct pathway in the initial free consultation.
The FDA’s official target review time is 90 days from acceptance. Real-world total time from submission to clearance is typically 4–9 months for a well-prepared submission. The most common causes of delays are insufficient predicate justification, incomplete testing data, and labeling deficiencies — all of which MDI addresses before submission. Scheduling a Q-submission (pre-Sub) meeting with the FDA before filing can also identify issues early and shorten total time.
mdi operates on a fixed-price model — you receive a total project cost before work begins, with no hourly billing and no surprise fees. Typical industry pricing ranges from $15,000–$80,000+ depending on device complexity, submission type, and whether testing guidance is included. mdi’s fee covers preparation of the complete 510(k) application and all FDA correspondence through clearance. The FDA user fee ($26,067 standard / $6,517 small business in FY2026) is paid separately and directly to FDA. Contact MDI for a no-obligation project quote.
Yes. The FDA requires all foreign establishments manufacturing medical devices intended for the U.S. market to designate a U.S. Agent under 21 CFR Part 807. A U.S. Agent must reside or maintain a place of business in the United States and be available to the FDA during business hours. Failure to designate a U.S. Agent can result in import alerts, rejection of shipments, or device listing refusal. MDI Consultants serves as U.S. Agent for numerous foreign manufacturers across Asia, Europe, and Latin America — this service can be combined with 510(k) consulting.
FDA user fees are updated annually each October. These figures are effective for fiscal year 2026.
| Submission type | Standard fee | Small business fee | Device class |
|---|---|---|---|
| 510(k) Premarket Notification | $26,067 | $6,517 | Class II |
| De Novo Classification Request | $173,782 | $43,446 | Class II (novel) |
| Premarket Approval (PMA) | $579,272 | $144,818 | Class III |
| FDA Establishment Registration | $11,423 | — | All classes |
Free consultation. Fixed price. Clearance guaranteed.
MDI has been getting devices to market since 1978.
Dear mdi Consultants Team,
I would like to thank you for your excellent efforts and commitment in assisting us to obtain 510(k) clearance. I am impressed with your dedicated ans professional FDA submission team that has helped us avoid unfavorable deficiencies that may have led to additional cost and time delay. Thank you once again and looking froward to working with you future projects.
Henry Kao, Regulatory Affairs Specialist
Carilex Medical, Inc
Your regulatory strategies for a 510(k) application versus an IDE/PMA saved the company from unwanted time delays and crippling financial setbacks. We are fortunate to have an organization like yours to support our efforts…Please feel free to forward any potential new clients to my attention for professional or personal references.
John Giungo, VP, Design and Development
Photogenesis
Dear Alan,
We want to thank mdi for your assistance with the most recent FDA inspection of our facilities in Taiwan.
Your guidance and composed demeanor throughout the inspection demonstrated your extensive experience and expertise in navigating FDA inspections and working with FDA investigators.
The inspection results were outstanding, and we cannot imagine going through future FDA inspections without the support of mdi. We strongly recommend mdi to any organization seeking assistance with the FDA.
Once again, we express our gratitude for your exceptional expertise and experience in ensuring the success of the inspection.
Best regards,
Jonathan Cheng, President
Merits Health Products Co., Ltd.