The premarket notification that shows a medical device is substantially equivalent to one already on the US market.
A 510(k) is a premarket submission to the FDA showing that a new medical device is as safe and effective as a device already legally on the US market, called the predicate. The FDA reviews the comparison and the supporting testing and, if it agrees, issues a clearance letter. Clearance is the route to market for most Class II devices.
It is named after section 510(k) of the Federal Food, Drug, and Cosmetic Act. Since 1 October 2023 a 510(k) is submitted electronically in the FDA's eSTAR format.
Manufacturers of a Class II device, and the Class I devices that are not exempt, before the device is sold in the United States
Manufacturers changing a cleared device, where the change could significantly affect safety or effectiveness or is a major change in intended use
Companies bringing a device to the US from another market, where CE marking or another market's clearance does not carry over
The work starts when the board asks for a US launch date, when a predicate is chosen and the testing plan is built around it, or when a design change lands and someone has to decide whether it needs a new submission.
The eSTAR walks the reviewer through the device and its comparison to the predicate. Every section is a document or a set of test results your team has to produce and approve.
What the device is, what it does and who it is for, with the labelling the FDA will read against the claims
The predicate, the comparison of intended use and technology, and the argument that any differences do not raise new questions of safety or effectiveness
Bench, and where needed animal and clinical, with the protocols, reports and the standards each test followed
The description, risk management file, requirements, architecture, verification and validation at the Basic or Enhanced documentation level, for devices that are or contain software
Each where the device calls for it, with the design controls behind them
The truthful and accuracy statement and the cover letter the FDA uses to log the submission
The predicate sets the comparison and the testing the FDA will expect, so this decision shapes everything after it.
Requirements, risk analysis, verification and validation, with each result approved and traceable to the requirement it proves.
With every document at its approved version and the comparison to the predicate written against the evidence.
The FDA checks the submission is complete, then reviews it against a 90-day goal, with additional information requests that stop the clock until answered.
The clearance letter lets the device be marketed. Every design change after it is assessed for whether it needs a new 510(k), and the next submission starts from this file.
THE 510(k) IN QUALIO
Qualio holds the requirements, the ISO 14971 risk file and the verification and validation results, read from Jira and TestRail as your engineers work, with the traceability between them rebuilt as the work changes. When the submission is due, it compiles the technical documentation from the approved versions, laid out in the eSTAR's own sections, and exports it. The file is kept with its approvals, so a design change later is assessed against it and the next submission starts from the last.
Every requirement traced to the risk it controls and the test that verifies it, so the substantial equivalence argument rests on evidence that is already approved
The software documentation section built from the requirements and tests traced from your repos, for devices that contain software
A design change assessed against the cleared file, so the decision on whether it needs a new 510(k) is made on the record, dated and signed
The 510(k) framework in the same library as ISO 13485 and the QMSR, so the quality system the FDA inspects and the file it clears are read together
Zalgen Labs manufacture diagnostic kits for the detection of deadly diseases, from Lassa and Ebola to SARS-CoV-2.
“Qualio gives everyone a roadmap in this time when we're having to move very quickly. Having that structure for everyone to work within is going to be essential for us to really succeed.”
Heather UnderwoodCEO, EvoEndoA 510(k) is a premarket submission to the FDA showing that a new medical device is substantially equivalent to a device already legally on the US market. The FDA reviews the comparison and the testing behind it and, if it agrees, issues a clearance letter that allows the device to be sold.
A 510(k) shows equivalence to a predicate and ends in clearance, and it is the route for most Class II devices. A PMA is a full demonstration of safety and effectiveness, usually with clinical data, and ends in approval, and it is the route for Class III devices. The words are not interchangeable.
The FDA's goal is a decision within 90 FDA days of receipt, and the clock stops each time the FDA asks for additional information. Most submissions take longer end to end once the testing before submission and the responses during review are counted.
No. Most Class I devices and some Class II devices are exempt and can be marketed after registration and listing. Class III devices need a PMA, and a novel low or moderate risk device with no predicate goes through De Novo instead. A 510(k) is required for the Class I and Class II devices that are not exempt.
Sometimes. A change that could significantly affect the device's safety or effectiveness, or that is a major change in intended use, needs a new submission. Other changes are documented in the design and development file with the reasoning. The FDA publishes guidance on how to decide, and the decision itself has to be recorded.
A finding that the new device has the same intended use as the predicate and either the same technological characteristics, or different ones that do not raise different questions of safety and effectiveness and are shown by testing to be as safe and effective. It is the whole argument of the submission.
Yes. The 510(k) framework in Qualio maps the submission's sections to the requirements, risk file, tests and documents you already hold, compiles the technical documentation from their approved versions and exports it in the submission's structure. The file is kept with its approvals, so the next submission starts from it.
Bring the date and your design controls, wherever they live. We will show you a 510(k) compiled from them, section by section, with the approval behind every document and the traceability behind every test.
Less time on documentation. More time on the device.
