Regulatory Strategy

AI Regulatory Strategy

Your team is building a medical device AI application. Now you (or your investors) are asking:

• What is our regulatory path onto the US market?
• Is it a 510(k) or De Novo?
• Is our training data acceptable?
• What clinical validation is needed?
• How much test data do we need?

Maybe your first Pre-Sub felt like a waste of time. Perhaps your regulatory team has insufficient AI expertise to answer these questions.

We can help you find a clear path to market. We’ve helped over __ companies answer these questions.

The Outcome

After completing our AI Regulatory Strategy process, you'll know

• A clear path to market
• How FDA expects you to validate your device
• Sample size and what types of data you'll need
• How many readers and their qualifications
• How long it will take
• Key regulatory risks

Imagine feeling confident that you’re investing your limited resources in the appropriate validation study. Imagine being able to answer your investors’ regulatory questions.

What Our Clients Say

They were proactive, informative, and very well-versed in the regulatory challenges of AI in medical imaging… Unlike competitors, who sometimes take a blanket approach, Innolitics didn’t throw the baby out with the bathwater. They recognized the good work already done and built upon it… We reviewed other capable firms, but none showed the same depth of understanding of the rapidly evolving landscape of AI and regulatory requirements. Their proactive stance with the FDA gave us confidence that we were in the right hands, compared to competitors who seemed more reactive.

Jagi Gill

Founder and Managing Director

Our Process

1. Develop and Submit Pre-Sub Documents to FDA (4 weeks)
   1. Document the model following FDA’s guidances and expectations
   2. Create an inventory of existing annotations and data sources so they can be reused in the validation study.
   3. Clarify the clinical workflow and intended use
   4. Research the regulatory landscape
   5. Design and document the clinical validation approach
   6. Compile and submit a Pre-Sub meeting with FDA
2. Hold the Pre-Sub meeting with FDA (60 days)
3. Debrief you on the outcome of the presub and implications on your development process

Why Innolitics

• Four AI/ML and image-processing experts on our team, including three PhDs and two MDs
• Six FDA regulatory consultants on staff
• All we do is medical-device software
• Developed software for over 70 medical devices since 2012

What Comes Next

FDA usually takes 60 days to hold a presubmission meeting. During this time, you may elect to begin work on your 510(k) or De Novo. We can guide you through the process or can rapidly accelerate it with our Fast 510(k) solution.

Pricing

Our AI Regulatory Strategy service is offered at a fixed price of $25,000, which includes:

• Comprehensive strategy development
• Pre-Submission preparation and FDA meeting support
• Regulatory risk assessment and mitigation planning

If your device involves multiple models providing independent functionality, or for other complex scenarios, we may require adjusted pricing.

FAQ

Top Regulatory Resources

Here are a few of the many articles we’ve published on regulatory strategy for AI/ML-enabled devices: