--- case_studies: - 141bd5b7-a754-80c4-8e9a-fa24807a2e59 - 14abd5b7-a754-80dc-ba3b-f361c0bcfd49 - 2a1bd5b7-a754-803b-a3be-cf14ba06b410 - 30abd5b7-a754-8063-90d4-ea45a37122f6 description: You need a strategy for bringing AI/ML-enabled software onto the US market. featured: false is_solution: true service_name: Regulatory Strategy sort_order: 4 title: Regulatory Strategy widget_icon: - /img/services/regulatory-strategy-5d7d68d6b3.svg --- ## 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 70 companies answer these questions.
Partner with Innolitics
## 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 ## Our Process 1. Develop and Submit Pre-Sub Documents to FDA (2 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](https://innolitics.com/services/guided-510k/) through the process or can rapidly accelerate it with our [Fast 510(k) solution](https://innolitics.com/services/510ks/). ## FAQ

Do all AI/ML-enabled devices require clinical validation?

If your AI model is used for triage, to detect disease, to diagnose disease, or is involved in guiding therapeutic decisions, then you will likely need to validate its performance using clinical data. That is, a reference standard that has been defined by clinical experts.

This is true even if your device as a clear predicate.

What is a Pre-Sub?

A Pre-Sub is a formal method for getting feedback from the FDA. See FDA Pre-Subs: Best Practices, FAQs, and Examples for more details.

Is one Pre-Sub always sufficient?

In many cases, we can find a path to market and an acceptable clinical validation strategy with a single Pre-Sub. Sometimes after the first Pre-Sub, there is remaining regulatory risk that requires further FDA interaction.

We’re very early stage. Is this service still appropriate?

Our AI Regulatory Strategy service is meant for companies who have a somewhat well-defined intended use and have made some progress developing their model. If you’re very early stage, you may want to consider our Initial Regulatory Assessment.

Can you work with our existing regulatory consultants?

Absolutely! We frequently consult with in house teams on topics related to AI/ML, software, and cybersecurity.

Can you help with other jurisdictions outside the US?

Unfortunately, no. Although most of our team members have experience with CE marking, Health Canada, UKCA, and other regulatory submissions—we’ve decided to focus just on the US market so that we can be experts in this jurisdiction.

We have partners we can coordinate with for international regulatory consulting.

Have other questions? Let’s talk!
## Top Regulatory Resources Here are a few of the [many articles](https://innolitics.com/articles/) we've published on regulatory strategy for AI/ML-enabled devices: