What is a 510(k) Submission for Medical Devices and IVDs?
A 510(k) submission is a premarket notification required by the US FDA to legally market a medical device or in vitro diagnostic (IVD) in the United States. 510(k) submissions are the regulatory pathway for most Class I and Class II medical devices (unless they are exempt) and some Class III devices that do not require Premarket Approval (PMA). It is a compilation of information that demonstrates that your device is “substantially equivalent” in safety and effectiveness to a legally marketed device already on the US market, known as a predicate device.
To establish substantial equivalence, the manufacturer must compare their device to one or more predicate devices, which may include devices cleared via 510(k), devices marketed before May 28, 1976 (i.e., pre-amendment devices), or devices authorized through the De Novo process. Once the FDA determines that the device is substantially equivalent, it issues a clearance letter, which immediately allows the product to enter the US market.
How to Prepare a Successful FDA 510(k) Submission
The FDA does not provide a standard form for 510(k) submissions but expects applicants to follow specific content and format requirements found in 21 CFR 807 Subpart E. Compiling a 510(k) that has a chance of being accepted by the FDA requires deep understanding of nuanced requirements and expectations and a plan to collect the required information. Here’s how we guide manufacturers through each step of the process:
Define FDA Product Code and Risk Classification
The foundation of a strong 510(k) submission starts with confirming the correct FDA product code and regulation number. Classification determines not only the applicable requirements, but also which guidance documents and recognized consensus standards will apply. It also clarifies the most efficient submission route, whether that’s a Traditional, Special, Abbreviated, or Safety and Performance-based 510(k). Learn more about FDA medical device classification.
Identify your Predicate Device(s)
A predicate must be a legally marketed device with similar intended use and technological characteristics to your own device. To find the right match, start by thoroughly reviewing FDA databases for cleared devices within the same product code and regulation number, and evaluate how closely each device aligns with your device’s design, materials, mode of operation, and clinical expectations. Your 510(k) should illustrate substantial equivalence in a clear, structured way that highlights key similarities in indications for use, performance, and technology. If your device deviates significantly in design, function, or technology from your predicate, you may need to support your claim with additional bench testing, animal studies, or clinical investigations to prove it is just as safe and effective as the predicate.
Conduct a Gap Analysis and Define Submission Needs
Once regulatory requirements are established, perform a detailed review of your current documentation, including design files, test data, labeling, risk management, and quality management system to inventory what’s in place and what’s still needed, depending on your device type. Determine which testing, standards, FDA guidance, and clinical data requirements apply to your device and create a strategy to gather the required information. Compile test reports and labeling information. Careful planning and documentation, particularly with regard to design controls, risk management, usability, and quality management, will set you up to move on quickly to the 510(k) preparation phase.
Compile and Submit Your FDA 510(k)
After all documentation gaps are addressed, it’s time to prepare the complete 510(k) submission. This includes compiling all required sections and creating a robust, point-by-point comparison between your device and the predicate. When complete, electronically submit your 510(k) to the FDA via eSTAR and pay the required fees to the FDA (eCopy submissions are no longer accepted). eStar is the interactive PDF form that has been created by FDA and guides applicants through the process of preparing a comprehensive medical device submission.
FDA Review Process for 510(k) Submissions
The FDA’s 510(k) review process includes the following phases:
Acceptance Review: The FDA checks if your submission meets basic acceptance criteria. The eStar template ensures your submission meets FDA’s acceptance criteria. However, if an eSTAR is deemed incomplete, it will be placed on hold and a replacement 510(k) must be submitted within 180 days.
Substantive Review: The FDA performs a detailed evaluation. You may need to address minor issues through an Interactive Review or provide additional information if requested.
Decision Letter: After review, the FDA issues a decision letter. If your device is deemed substantially equivalent (SE), it is cleared for marketing. If not, the FDA will issue a Not Substantially Equivalent (NSE) decision, and a new 510)k) submission or alternative routes like the De Novo process may be required.
