FDA Medical Device Clearance: 510(k) Submission and Review

Most medical devices reach the U.S. market through the FDA’s 510(k) clearance process, a premarket notification that shows your device is substantially equivalent to one already legally sold. For fiscal year 2026, the standard 510(k) user fee is $26,067, and the FDA aims to reach a decision within 90 FDA Days of accepting a submission.¹ Clearance is not approval. Approval is reserved for high-risk Class III devices going through Premarket Approval; 510(k) is a comparison exercise, and getting the comparison right is most of the work.

Do You Actually Need a 510(k)?

The answer depends on your device’s classification. The FDA sorts every medical device into one of three risk-based classes.

Class I devices are the lowest risk (elastic bandages, tongue depressors). Most require only general controls, and the majority are exempt from needing a 510(k).
Class II devices carry moderate risk (infusion pumps, powered wheelchairs, pregnancy tests). These need general and special controls, and most require 510(k) clearance.
Class III devices are life-sustaining or implanted (heart valves, pacemakers). These typically require Premarket Approval rather than a 510(k).

Even within Class I and Class II, some product codes carry exemptions from premarket notification. Exemptions apply only to devices with the existing or reasonably foreseeable characteristics of commercially distributed devices in that generic type. A Class I device loses its exemption if it’s intended for a use of substantial importance in preventing impairment of health, or if it presents a potential unreasonable risk of illness or injury. The FDA’s Product Classification database is the fastest way to confirm whether a specific product code is exempt.²

If your device is genuinely novel and has no predicate on the market, the 510(k) route doesn’t fit. A novel low- or moderate-risk device goes through the De Novo classification pathway instead, either after receiving a “not substantially equivalent” determination on a 510(k) or by direct submission when you already know no predicate exists.³

The Substantial Equivalence Standard

The 510(k) process turns on a single legal question: is your device substantially equivalent to a device already on the market? That existing device is your predicate. Substantial equivalence does not mean the two devices are identical. It means your device has the same intended use as the predicate and either shares the same technological characteristics or, if the technology differs, the differences do not raise new questions of safety or effectiveness.⁴

When technology differs, the FDA looks at whether there’s been a significant change in materials, design, energy source, or other features. You then have to provide clinical or scientific data showing your device performs as safely and effectively as the predicate, and that the changes don’t introduce different safety or effectiveness questions.

A valid predicate can be any legally marketed device: one previously cleared through a 510(k), a preamendments device marketed before May 28, 1976, a device reclassified from Class III to a lower class, or even a 510(k)-exempt device.⁵ Choosing the predicate is one of the most consequential decisions in the entire process. A weak predicate choice can unravel a submission months into review, when reviewers conclude the comparison does not hold up.

Which 510(k) Submission Type Fits Your Situation

The FDA offers three submission tracks and a third-party option.

Traditional 510(k)

This is the default: a full technical dossier making the case for substantial equivalence from scratch. Use it when neither streamlined program fits.

Special 510(k)

The Special 510(k) is available when you are modifying your own previously cleared device and the methods to evaluate those changes are well established. You can present data in a summary or risk-analysis format rather than a full dossier. Performance data must either be unnecessary for the specific change or generatable using accepted test methods, and you must be the same entity legally authorized to market the original device.⁶

Abbreviated 510(k)

The Abbreviated 510(k) works when an FDA guidance document, established special controls, or a recognized voluntary consensus standard covers performance expectations for your device type. Instead of raw test data, you submit summary reports of how you followed the guidance or a declaration of conformity to the standard.⁶

Third-Party Review

For eligible device types, you can submit to an FDA-accredited third-party review organization instead of directly to the agency. The reviewer sends a recommendation to the FDA, which makes a final decision within 30 days of receiving it. Eligibility is set at the product code level, and the FDA publishes the qualifying list.⁷

What Goes in the Submission

Every 510(k) is built around a technical dossier that identifies a valid predicate, compares intended uses and technological characteristics, and presents performance data that bridges any gaps.

Performance and Biocompatibility Testing

Bench testing carries most submissions: mechanical strength, electrical safety, and any other performance metrics that matter for your device type. If your device contacts human tissue directly or indirectly, you’ll need biocompatibility data showing the materials won’t cause toxic, allergic, or other harmful biological responses. Devices with no tissue contact are exempt.⁸ The FDA follows ISO 10993-1 for biological safety evaluation, covering endpoints from cytotoxicity and sensitization to genotoxicity and implantation effects.⁹

When You’ll Need Clinical Data

Most 510(k) submissions rely on bench and animal testing, consistent with the “least burdensome” principle. Clinical data may be needed in four scenarios: your device has different indications for use than the predicate; the technological changes are significant enough to require human performance evidence; bench or animal testing can’t adequately predict clinical outcomes; or new postmarket information has revealed previously unrecognized risks in the predicate itself.¹⁰ Acceptable clinical data can come from traditional investigations, published literature, registries, adverse event databases, or electronic health records.

Software and Cybersecurity Documentation

Devices with software require validation and verification documentation. For any device meeting the “cyber device” definition under Section 524B of the FD&C Act, requirements go further. You must submit a Software Bill of Materials listing all commercial, open-source, and off-the-shelf software components. You also need a plan for monitoring and addressing postmarket cybersecurity vulnerabilities, and evidence that the device was designed with processes to deliver security patches and updates.¹¹ The SBOM should include each component’s level of support status, end-of-support date, and an assessment of known vulnerabilities.¹²

510(k) Summary or Statement

Every submission includes either a 510(k) Summary or a 510(k) Statement. The Summary is a structured overview of the safety and effectiveness comparison covering predicate identification, device description, intended use, technological comparison, and testing conclusions.¹³ The Statement is a signed certification that you’ll provide the full safety and effectiveness information to anyone who requests it within 30 days, excluding trade secrets and patient identifiers.¹⁴ Most manufacturers file the Summary because it puts the data directly in front of reviewers.

Submission Format

Since October 1, 2023, all 510(k) submissions to the Center for Devices and Radiological Health must use the electronic Submission Template and Resource (eSTAR), an interactive PDF that walks you through each required field and attachment. The old eCopy format is no longer accepted.¹⁵

User Fees and Small Business Qualification

The FDA collects a user fee before reviewing any 510(k). For fiscal year 2026, the standard fee is $26,067. Small businesses with gross receipts or sales of $100 million or less, counting affiliates, qualify for a reduced fee of $6,517, which is 25% of the standard rate.¹

To pay the reduced rate, submit Form FDA 3602N through the CDRH Portal at least 60 days before filing the 510(k), along with your most recent federal income tax return.¹⁶ The fee is due when you submit. If the FDA doesn’t receive the correct amount, the application won’t be accepted for review.

Review Timeline: Acceptance, FDA Days, and the 180-Day Response Rule

Within 15 calendar days of receiving your submission, the FDA completes an Acceptance Review. You’ll get one of three outcomes by electronic notification: the 510(k) was accepted for substantive review, it was refused (a “Refuse to Accept” or RTA), or the FDA didn’t finish the acceptance check in time and the submission moves to substantive review by default.¹⁷

Once accepted, the FDA’s performance goal is a decision within 90 FDA Days, calculated as calendar days minus any time the submission spends on hold. The most common hold is an Additional Information (AI) request, where the reviewer identifies deficiencies or asks for clarification.

The AI response deadline is unforgiving. You get 180 calendar days to respond, and there are no extensions. If the deadline passes without a complete response, the FDA considers the submission withdrawn and deletes it from the review system. Some manufacturers learn this the hard way.¹⁷

After Clearance: What You Still Have to Do

A clearance letter starts a set of ongoing obligations rather than ending them.

Labeling

Labeling has to meet 21 CFR Part 801 before the device can ship. Every label must include the name and business address of the manufacturer, packer, or distributor. If the named entity did not make the device, a qualifying phrase such as “Manufactured for” or “Distributed by” is required. Labels also need adequate directions for use, written so a layperson can use the device safely for its intended purpose.¹⁸

Every device and package must carry a Unique Device Identifier in both plain human-readable text and a machine-readable format such as a barcode. Any printed dates must follow YYYY-MM-DD. Over-the-counter devices carry extra requirements including a statement of identity on the principal display panel and a net quantity declaration in boldface type.¹⁸

Promoting a cleared device for uses beyond what the FDA cleared, known as off-label promotion, creates serious exposure. The FDA treats your promotional statements as evidence of the device’s intended use, and off-label marketing can render the device misbranded or adulterated. Genuinely unsolicited requests for off-label information can be answered, but only through private, non-promotional, scientifically balanced communications generated independently of the sales team.¹⁹

Establishment Registration and Listing

Every facility involved in manufacturing, preparing, or processing a device for the U.S. market must register annually with the FDA and list its devices. The FY 2026 annual establishment registration fee is $11,423.¹ Small businesses with gross receipts of $1 million or less that can show financial hardship may qualify for a waiver of the registration fee, though not for the initial registration year.²⁰

Quality Management System

Manufacturers must maintain a quality management system under 21 CFR Part 820. As of February 2, 2026, that regulation has been revised and retitled the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference and aligns U.S. requirements with the framework used in most other countries.²¹ Companies already certified to ISO 13485 will find the transition straightforward. Those that aren’t face a documentation overhaul.

Medical Device Reporting

Manufacturers and importers must report to the FDA when they become aware their device may have caused or contributed to a death, serious injury, or certain malfunctions. Manufacturers have 30 calendar days from awareness of a reportable event to file an individual adverse event report.²² Hospitals, nursing homes, and other user facilities carry parallel obligations for deaths and serious injuries.

Corrections and Removals

When you initiate a correction or removal to reduce a health risk or remedy a violation of federal law, a written report must go to the FDA within 10 working days. The report identifies the device, describes the problem, details the corrective action, notes any associated injuries, and lists consignees with distribution dates and quantities. If the action later extends to additional lots, you have another 10 working days to amend. Corrections that don’t trigger reporting still have to be documented and retained for two years beyond the device’s expected life.²³

Penalties for Non-Compliance

For 2026, civil money penalties for device-related violations can reach $35,466 per individual violation and $2,364,503 in aggregate for all violations adjudicated in a single proceeding.²⁴ Beyond fines, the FDA can seize violative devices, seek injunctions to halt distribution, and negotiate consent decrees that impose detailed corrective action plans and ongoing monitoring.²⁵ Correcting a device program after an enforcement action almost always costs more than building it correctly at the outset.

1
Federal Register. Medical Device User Fee Rates for Fiscal Year 2026
2
U.S. Food and Drug Administration. Class I and Class II Device Exemptions
3
U.S. Food and Drug Administration. De Novo Classification Request
4
U.S. Food and Drug Administration. Evaluating Substantial Equivalence in Premarket Notifications 510(k)
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U.S. Food and Drug Administration. How to Find and Effectively Use Predicate Devices
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U.S. Food and Drug Administration. 510(k) Submission Programs
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U.S. Food and Drug Administration. 510(k) Third Party Review Program
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U.S. Food and Drug Administration. Basics of Biocompatibility Information Needed for Assessment by the FDA
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U.S. Food and Drug Administration. Use of International Standard ISO 10993-1 Biological Evaluation of Medical Devices
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U.S. Food and Drug Administration. Recommendations for the Use of Clinical Data in Premarket Notification 510(k) Submissions
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U.S. Food and Drug Administration. Cybersecurity in Medical Devices Frequently Asked Questions
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U.S. Food and Drug Administration. Cybersecurity in Medical Devices Quality Management System Considerations and Content of Premarket Submissions
13
eCFR. 21 CFR 807.92 – Content and Format of a 510(k) Summary
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eCFR. 21 CFR 807.93 – Content and Format of a 510(k) Statement
15
U.S. Food and Drug Administration. eSTAR Program
16
U.S. Food and Drug Administration. Reduced or Waived Medical Device User Fees SBD Program
17
U.S. Food and Drug Administration. 510(k) Submission Process
18
eCFR. 21 CFR Part 801 – Labeling
19
U.S. Food and Drug Administration. Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices
20
U.S. Food and Drug Administration. Device Registration and Listing
21
U.S. Food and Drug Administration. Quality Management System Regulation QMSR
22
eCFR. 21 CFR Part 803 – Medical Device Reporting
23
eCFR. 21 CFR Part 806 – Medical Devices Reports of Corrections and Removals
24
Federal Register. Annual Civil Monetary Penalties Inflation Adjustment
25
U.S. Food and Drug Administration. Regulatory Procedures Manual