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.
Our Pragmatic Philosophy
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!
We’ve Helped Others Like You
Innolitics’ team epitomized proficiency, professionalism, and precision. Their expertise extends beyond FDA regulations, encompassing intricate facets of DICOM, radiology workflows, and adept software engineering. Venturing into this without their support would have potentially stretched our timeline to 9 months or more. Earning the FDA clearance (K231385), for us, is more than just an accomplishment; it’s a monumental milestone.
Amr Abodraiaa
CEO of Rology
Thanks to Innolitics, we were able to complete the software documentation for our 510(k) in just 4 months. They flew onsite to absorb how our software worked and provided detailed guidance. Without Medtech OS, training, and support, I can easily imagine the process taking 12 months. Our engineering team was able to focus on feature development instead of being bogged down with documentation. We tried three different consultants before finding Innolitics. None of them could deliver. Innolitics took the reins and made it happen. I don’t see how we would have completed our 510(k) without them.
VP of Systems R&D
IVD Startup
Product Types
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
Our Process
Team Training and Guidance
We believe in empowering your team for not just the current submission but for future regulatory success. Our services include:
Guided Walkthroughs: Navigating you through the 510(k) submission process with clarity and precision.
Hands On Guidance: We don’t just give you templates, we provide concrete, specific examples and advice for your Engineers.
Document Review: We can review your documentation for gaps.
Determining “How Much is Enough”: With much of the FDA guidance, it is often difficult to know “how much is enough”. We’ve helped companies with their 510(k) clearance, so we can help you strike the right balance between complying with FDA’s expectations while not going out of business (and thus never bringing your technology to help patients).
Documentation Support
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:
Security Risk Management and Threat Modeling
Cybersecurity Controls
Cybersecurity Testing
SBOM Generation
Postmarket Cybersecurity Processes
Why Choose Our Guided 510(k) Service?
Dual Expertise: Our unique combination of software development and regulatory knowledge offers a comprehensive perspective that covers all bases of your 510(k) submission.
Customized Support: From training sessions to document preparation, our services are tailored to meet your project's specific needs.
Cybersecurity Emphasis: With a strong focus on cybersecurity, we ensure that your submission meets the latest FDA guidance, protecting your device and your end-users.
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 at an hourly rate and is
flexible. The costs involved start at $25k for the most basic review up
through $75k when much more in-depth support is required.
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.
What is the difference between the Guided 510(k) and Fast 510(k) services?
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.
How long does the Guided 510(k) process typically take?
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.
Do you provide cybersecurity documentation support as part of the Guided 510(k) service?
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.
Can you help with regulatory strategy as part of the Guided 510(k) service?
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.
What if we need more hands-on support during the Guided 510(k) process?
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.
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