Services/510(k) & Regulatory
FDA 510(k) & Regulatory Compliance
Bringing a medical device to market in the US requires a structured regulatory strategy. SiGenix supports clients from initial device classification through 510(k) submission — writing the technical documentation, coordinating performance testing, and responding to FDA questions until clearance.
Navigating the FDA Clearance Process
A 510(k) is an argument: that your device is substantially equivalent to one already on the market. Building that argument well starts long before the submission is written — with the right predicate device strategy, a test plan that generates the evidence FDA expects, and design documentation that holds together under review.
Because SiGenix does the engineering as well as the regulatory work, the technical documentation in your submission describes the device as it was actually designed and tested — not a paperwork layer bolted on afterward. We have supported 510(k) submissions for Class II devices and hold patents on the cleared technologies behind them.
What Our Regulatory Support Includes
Classification & Predicate Strategy
Device classification analysis and predicate device selection — the foundation that determines your regulatory pathway and the strength of your substantial equivalence argument.
Substantial Equivalence Argument
Development of the substantial equivalence comparison at the core of the 510(k) — intended use, technological characteristics, and supporting performance data.
Technical Documentation
Assembly of the technical file and design documentation — device description, specifications, software documentation, and risk analysis — in the structure FDA reviewers expect.
Performance & Bench Testing
Bench test protocol development and execution to generate the verification evidence that supports your substantial equivalence claims.
Pre-Submission (Q-Sub) Meetings
Preparation for FDA pre-submission meetings — framing the right questions and presenting your device so you get actionable feedback before committing to a test plan.
FDA Correspondence
Responses to FDA additional information (AI) requests during review — addressing reviewer questions with data and argument rather than delay.
Patented Technologies
Regulatory Work Behind Cleared, Patented Devices
Frequently Asked Questions
What is a 510(k) submission?
A 510(k) is the FDA premarket notification pathway for most Class II medical devices. It demonstrates that your device is substantially equivalent to a legally marketed predicate device — supported by performance testing, risk analysis, and technical documentation.
Do you write the 510(k) submission itself?
Yes. We develop the substantial equivalence argument, assemble the technical documentation and test evidence, and prepare the submission — then respond to FDA additional information requests during review.
What is an FDA pre-submission (Q-Sub) meeting?
A pre-submission meeting lets you ask FDA specific questions about your device and test plan before submitting. We prepare the briefing package and frame the questions so you get clear, actionable feedback — reducing the risk of surprises during review.
Can you help if FDA has already asked for more information?
Yes. We respond to additional information (AI) requests on in-review submissions — analyzing what the reviewer is actually asking for, running any needed testing, and drafting responses backed by data.
Planning a 510(k) — or stuck in one?
Whether you're choosing a regulatory pathway or responding to FDA questions, tell us where your submission stands and we'll tell you honestly how we can help.
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