Navigating the path to FDA 510(k) clearance can be daunting, especially for companies seeking clearance for their first product. Our "Guided 510(k)" service is designed to simplify this journey.
Unlike our Fast 510(k) solution, where we rapidly write most of the documentation for your team on a fixed-price basis, our Guided 510(k) is for teams that want to do most of the work themselves, but need training, templates, and document review support. We can tailor our engagements to meet your needs and budget.
We work with startups who have limited resources to bring their impactful technologies onto the US market. We therefore take a pragmatic approach to FDA regulations. We start with common sense, focusing on the activities that we believe make the device safe. When it comes to activities that are required by FDA, we help companies strike the right balance.
Regulatory consultants at large companies try to make their submissions iron-clad. We do not. Instead, we will guide you towards a submission that strikes a balance and we let FDA request additional information where they feel it is needed. A submission without an FDA request for additional information means too many resources have been spent!
Our team has FDA cleared more than 100 SaMD and SiMD products.
Although we can provide excellent support for AI-enabled SaMD, we have especially deep experience in the following FDA product codes:
| FDA Product Code | Description |
|---|---|
| QIH | Automated radiological image processing software |
| LLZ | Medical image management and processing systems |
| IYE | Medical charged-particle radiation therapy systems |
| QJG | Device system, imaging, tympanic membrane and middle ear |
| POK | Computer-assisted diagnostic software for lesions suspicious for cancer |
| QFM | Radiological computer aided triage and notification software |
| QCB | Radiological image processing software for radiation therapy |
| LNH | System, nuclear magnetic resonance imaging |
| MYN | Medical image analyzer |
| QDQ | Radiological computer assisted detection/diagnosis software for lesions suspicious for cancer |
| QAS | Radiological computer-assisted triage and notification software |
We believe in empowering your team for not just the current submission but for future regulatory success. Our services include:
Understanding the critical role of documentation in the 510(k) process, we offer our suite of tried-and true SaMD templates that cover the latest FDA Guidance, including, but not limited to:
With the FDA's increasing emphasis on cybersecurity, our service places a significant focus on ensuring your SaMD meets the FDA’s stringent of cybersecurity regulations. We provide in-depth guidance for all stages of the device's lifecycle, from design to post-market surveillance, including:
With our "Guided 510(k)" service, your first step into the medical device market is supported by experts who understand both the technology and the regulatory framework. Contact us today to learn how we can help your SaMD or SiMD achieve FDA 510(k) clearance, paving the way for your innovative solutions to make a meaningful impact in healthcare.
Our Guided 510(k) service is billed as a monthly retainer. The size of the retainer is set based on your submission timeline, the experience of your team, and the state of the software and documentation. Typical retainers range from $10k/month to $15k/month.
Prices tend to be higher if you are early in product development, as it will increase the rework that needs to be done as requirements/needs evolve.
The Guided 510(k) service is designed for teams that want to do most of the work themselves but need training, templates, and document review support. Our Fast 510(k) service, on the other hand, is where we rapidly write most of the documentation for your team on a fixed-price basis.
The duration can vary depending on your team's availability and the complexity of your device. However, with our guidance and templates, many teams can complete their 510(k) documentation in 6 - 9 months, which is significantly faster than doing it independently without expert support. Our Fast 510(k) is much faster and requires less effort from your team.
Yes, we do. Our Guided 510(k) service includes support for cybersecurity documentation, which is crucial given FDA's increasing emphasis on this area. We can help you navigate the latest FDA cybersecurity guidance and ensure your submission meets current expectations.
Our Guided 510(k) solution focuses on preparing the 510(k) submission, and comes after the development of a regulatory strategy. For more comprehensive regulatory strategy, especially for AI/ML devices, you might want to consider our dedicated Regulatory Strategy service.
Our Guided 510(k) service is flexible. If you find you need more support during the process, we can adjust our level of involvement. In some cases, if extensive support is needed, we might recommend transitioning to our Fast 510(k) service for more comprehensive assistance.
Here are a few of the many articles we’ve published on regulatory strategy for AI/ML-enabled devices:
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