Want to get the FDA 510k approval for your medical device and IVDs (In vitro Diagnostic devices)? Maven regulatory consultants guide you for your US FDA 510k process.
Traditional 510k submission
Special 510k submission
Abbreviated 510k submission
These submissions are a bit tedious and consist of multiple steps and testing requirements. Appropriate planning, support from your end, and guidance from our end would make this 510k submission process much simpler.
These 510k are the pre-market notifications! Once cleared, the organization can go ahead with the marketing process.
The FDA recognizes three types of 510(k) submissions — Traditional, Special, and Abbreviated — each described in dedicated guidance documents that outline their respective requirements and review approaches.
Don’t get confused between these types. Each comes with its own advantages and limitations. You will still need to show the equivalence of your device with an already marketed device in the US. Working with our experienced US FDA consultants can make this process smoother and help you navigate the complex requirements effectively, especially if you’re looking for reliable FDA medical device consulting services.
Let’s Talk About the Traditional 510K Submission
The Traditional 510K submission is the most common pathway for medical device manufacturers seeking US FDA 510k certification or 510k approval. This process involves providing comprehensive documentation to demonstrate that your device is substantially equivalent to a predicate device already on the market. Our FDA consultants will guide you through the steps, ensuring your submission is complete and compliant. With our experienced FDA medical device consultants, you can streamline the process and avoid common pitfalls, ensuring a faster path to market. As trusted 510k consultants, we offer expert advice throughout your journey, helping you navigate the complexities of FDA approval.
Special 510K Submissions
The Special 510K submission was primarily established to streamline and make the review process of device changes more efficient.
If you need to modify a device that is already available in the US market, the Special 510K is the ideal pathway because it focuses mainly on meeting the design controls requirements under 21 CFR 820.30 for both the device in scope and the predicate device, and since the device is already established in the US, the review timeline is typically much faster than the traditional route; for smoother preparation and submission, working with experienced 510k submission consultants can help you avoid delays and ensure everything is aligned with FDA expectations.
For guidance through this process, working with our US FDA 510k consultants can help ensure a smoother submission. A regulatory consultant for medical devices will assist in meeting all the necessary requirements, ensuring your modifications are well-documented and fully compliant with FDA medical device regulations. Whether you need support for US FDA 510(k) certification, the FDA Traditional 510k pathway or broader submission assistance, partnering with an experienced medical device FDA consultant can help you navigate the process efficiently and avoid delays.
What is an Abbreviated FDA 510K Submission?
An Abbreviated FDA 510(k) Submission is a streamlined process for gaining FDA clearance for medical devices that are substantially equivalent to an already legally marketed device. This type of submission is typically used when there is a relevant renowned standard for your specific medical device or when a specific FDA guidance document is available for the device classification. If your device meets these criteria, you may opt for an Abbreviated 510(k) submission to demonstrate its conformity with the necessary regulatory requirements. Working with experienced FDA 510k consultants can help ensure your submission is thorough and meets the FDA’s expectations. Medical device FDA consulting services can provide expert advice on whether this submission type is right for your device, simplifying the process and improving the chances of clearance.
Timelines for FDA 510K Approval and Clearance
After the submission of a 510K application, the review process typically takes between 60 to 90 days. If any queries are raised or additional documents are required, an Additional Information (AI) request will be issued, or a Refuse To Accept (RTA) notice may be given if the submission does not meet the required standards. In such cases, re-submissions must be completed within a 180-day timeline. Our regulatory consultant guidance in ensuring a smooth and timely US FDA 510(k) submissions process.
Stages of the FDA 510K Process with Maven Consulting
One-Stop Solution for US FDA 510K Consulting Services
Maven is one of the best regulatory consultancy company for USFDA 510k services for your product.
Our vision is to be the interactive, timely follow-up for the requirements, and We provide end-to-end service to get the “510k approved” tag for your product.
Our set of strategies includes a complete framework of detailed planning for the project and its execution, from data collection to fee payment to USFDA.
A timely solution to the critical aspects of the project, detailed knowledge of the requirements, and collaboration with testing facilities allow us to make an effective submission to US FDA 510k, making MAVEN the one-stop solution for USFDA 510k. With our FDA medical device consulting expertise and the experience of working with renowned FDA consulting firms, we ensure your submission process is seamless. Our team, consisting of highly skilled medical device regulatory consultants, guides you through the entire process, offering tailored FDA medical device consulting consulting services to meet your unique needs.
Why Choose Maven for US FDA 510(k) Consulting and Approval
At Maven, our team has strong experience in US FDA 510(k) consulting. We provide practical, easy-to-follow regulatory solutions tailored to your product and medical device requirements.
We act as your trusted partner, ensuring every project is completed on time and with attention to detail. Our focus is on quality, clear communication, and helping you save both time and cost.
We act as your trusted partner, ensuring every project is completed on time and with attention to detail. Our focus is on quality, clear communication, and helping you save both time and cost.
FAQ:
The cost of FDA 510(k) consulting depends on the type of medical device and its intended use. At Maven, our FDA consultant fees start at $18,000 for non-implantable devices and $20,000 for implantable devices.
For Fiscal Year 2025, the official USFDA 510(k) submission fee is $24,335 (standard) or $6,084 (small business fee). After clearance, manufacturers are also required to pay the FDA establishment registration fee of $9,280.
Final pricing may vary depending on device specifications, models, and additional regulatory requirements. Please note that testing costs are not included in the above fees.
A Premarket Notification (510(k)) is a type of premarket submission that is intended to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (21 CFR 807.92(a)(3)) that does not require PMA. To determine if a device is substantially equivalent (SE), FDA considers intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labelling, biocompatibility, standards, and other characteristics, as applicable.
A 510(k) submitter/holder is the owner of the 510(k). Although, a consultant or correspondent may submit the 510(k) on behalf of the 510(k) owner, that consultant or correspondent is not the 510(k) submitter/holder.
A legally marketed device is a device that was legally marketed before May 28, 1976 (i.e., amendments), reclassified from class III to class II or class I, found substantially equivalent through a 510(k), or granted marketing authorization through the De Novo classification process. The legally marketed device(s) to which the submitter claims equivalence is commonly known as the “predicate.”
A Traditional 510(k) is the most common type of 510(k). In a Traditional 510(k), the submitter provides descriptive information about the indications for use and technology and results of performance testing to demonstrate substantial equivalence.
An Abbreviated 510(k) provides an effective means of facilitating the review of data in a 510(k) through reliance on one or more: FDA guidance document(s); Special controls; or Voluntary consensus standard(s).
A predicate device is an already legally marketed medical device in the United States that is used as a benchmark to demonstrate that a new device is substantially equivalent in terms of safety and effectiveness. When submitting a 510(k) premarket notification to the FDA, manufacturers must compare their device to a predicate device to justify that the new product does not raise new questions of safety or efficacy. This comparison includes aspects like intended use, technological characteristics, and performance data. The predicate device must belong to the same device classification and be cleared through the 510(k) process. Selecting the right predicate is crucial, as it forms the foundation of your submission. With proper guidance from experienced FDA 510k consultants, manufacturers can confidently identify and use an appropriate predicate device, ensuring a smoother and faster approval process. Predicate selection is one of the most strategic parts of FDA 510k submission and can significantly impact your clearance timeline.
Submitting a 510(k) for medical device approval involves a detailed and strategic process to ensure FDA compliance. First, you must determine if your device requires a 510(k) submission by identifying an appropriate predicate device with similar intended use and technological characteristics. Once confirmed, the next step is to gather and compile comprehensive documentation including device description, labeling, performance testing results, sterilization validation (if applicable), and risk analysis.
The FDA mandates that all 510(k) submissions be submitted electronically using the eCopy program. Your submission should also include a signed Truthful and Accuracy Statement, a Cover Letter, and a completed FDA Form 3514. Once submitted, the FDA assigns a K-number and begins its review. During this process, the FDA may issue an RTA (Refuse to Accept) checklist or Additional Information (AI) requests.
Working with an experienced FDA 510k consultant can greatly streamline the submission process, helping you avoid delays and ensuring your documentation meets all regulatory expectations. A well-prepared submission increases the likelihood of a quicker clearance, enabling you to launch your product in the U.S. market without unnecessary hurdles.
The Traditional 510(k) is the standard FDA submission pathway for medical devices seeking market clearance. It requires comprehensive documentation, including detailed device descriptions, performance data, predicate device comparisons, and testing results. This route is typically used when introducing a new device to the U.S. market or making significant changes that impact a device’s intended use or fundamental technology.
In contrast, the Special 510(k) is designed for manufacturers making modifications to their own legally marketed devices, where the changes do not affect the intended use or alter the fundamental scientific technology. The submission focuses heavily on design control documentation as per 21 CFR 820.30. Because the FDA already has familiarity with the original device, this pathway generally allows for faster review times, often around 30 days.
The FDA 510k listing is the process where medical device manufacturers notify the U.S. FDA before marketing their device by submitting a 510k premarket notification. It demonstrates that the new device is substantially equivalent to a legally marketed device, allowing it to be listed and sold in the U.S. market.
