--- case_studies: - 2a1bd5b7-a754-803b-a3be-cf14ba06b410 - a4b2d790-f1ff-47bb-93b2-09b0d4619030 - 5a6365b6-8971-407c-9e10-f60e6a194d08 - 30abd5b7-a754-8063-90d4-ea45a37122f6 - 35cbd5b7-a754-80f4-9a3c-cc0e62e41d52 description: We guarantee submitting your presub and BDD in 4 weeks. Need it faster? We can do it in as little as 2 weeks with daily meetings and a rush fee. featured: true is_solution: true service_name: Regulatory Strategy, Q-Sub, and BDD in 4 Weeks sort_order: 10 title: Regulatory Strategy and Pre-Sub widget_icon: - /img/services/regulatory-strategy-q-sub-and-bdd-in-4-weeks-5d7d68d6b3.svg ---
# Transforming Uncertainty into Strategic Clarity for CEOs and Senior Executives
- Your investors and board are asking about your regulatory strategy, study design, required fundraise, and what you'll use the money for but you are not sure what to say - You are about to spend \$1M+ on a clinical study. You only get one shot at this and want to make sure it will result in an FDA clearance. Getting this wrong will be a costly mistake. - **Uncertain Regulatory Pathways** - Without clear guidance, it\'s difficult to know which route to FDA clearance is fastest and most certain. Without clear guidance, it is impossible to know how much it will all cost and how long it will all take - **Breakthrough Device Designation Uncertainty** - Determining eligibility and successfully applying for expedited FDA review status is complex and unclear. The BDD can help you get funded. - Here\'s the challenge: - **You can\'t afford a failed submission or delays** - **Your team is already overloaded, nonexistent, or lacks the skills to execute with speed and certainty** - **Every month that goes by is another month you could be making revenue and securing market share from competitors**
You need peace of mind and certainty.
1. **You need one partner who can guarantee speed and success.** 2. **You need one partner who can just take it off your hands and do it for you on autopilot.**
![](/img/services/Regulatory_Strategy_Q-Sub_and_BDD_in_4_Weeks-2c2bd5b7a754802d8183c1af3d923553.jpg)
# Let's Go! Let us clarify your pathway from AI prototype to commercializable AI In a 30-minute call.
Let's Meet!
## Our Speed and Certainty Promise 1. **We guarantee a Pre-Submission Package will be submitted in as little as 4 weeks** or a partial refund will be issued. Need it faster? We can deliver in as little as 2 weeks with daily meetings and a rush fee. 2. **We guarantee FDA clearance** If you follow the strategy and partner with Innolitics to lead your FDA application, or a partial refund will be issued. 3. **We guarantee your breakthrough device designation** will be granted or a partial refund will be issued. ## Qualification Criteria Not all devices qualify for our service. Some existing qualification criteria are: 1. You should have an early version of the AI/ML algorithm completed so we can give FDA an intended use statement, achievable acceptance criteria, and design a clinical study to substantiate the marketing claims 2. Regulatory strategy and FDA clearance should to be the top priority of the organization for the duration of the strategy service 3. Is a software only device or you already have the strategy for the hardware side covered
See if you Qualify!
## Our Process: Battle-Tested. Speed and Certainty Guaranteed. Unlike traditional consulting firms that hand you templates and wish you luck, we drive the entire process with our full-stack team of MDs, PhDs, engineers, and regulatory consultants. We guarantee speed and certainty to success---delivering your regulatory strategy and pre-submission in as little as 4 weeks, with a clear path to FDA clearance. For teams on a tighter timeline, we offer a 2-week accelerated track that includes daily meetings and a rush fee. ### What You Will Gain: - Comprehensive regulatory strategy document with: - Product code determination - Identified predicate devices (for 510(k)) - Clinical validation strategy - Key marketing claims alignment - Regulatory risk assessment and mitigation strategies - Future submission roadmap - Complete FDA pre-submission eSTAR package - Statistical power studies for sample size justification - Clinical and standalone performance testing plans - FDA meeting preparation and representation **In the highest level of service tier, the regulatory strategy will be completed within 4 weeks of project commencement. An accelerated 2-week option is available with daily meetings and a rush fee.**

Click for more detailed service description

Identifying an optimal regulatory strategy is a multi-variate optimization problem with many variables including budget, timeline, investor milestones, marketing claims, data availability, ease of clinical assessment, presence of a strong predicate.

Our engineers, clinical, and regulatory experts will work with you to find the most optimal solution to get you on the market as soon as possible, following these steps:

  1. Understanding the Business Goals
    • What are you trying to accomplish by bringing the SaMD to market?
    • What markets do you want to sell it in and what is their relative importance?
    • What marketing claims do you need to be able to make about the device’s performance to accomplish these business goals?
    • How will the software be used (e.g., within the clinical workflow or directly by patients)?
    • Draft a rough intended use statement for the device.
  2. Understanding the Software and Clinical Workflow
    • What work has been done on the software?
    • What do you hope to implement in the next year or two?
    • What functionality is the highest risk?
  3. Researching the Regulatory Strategy
    • Determine the product code for the device
    • Identify applicable FDA guidance and Standards
    • Determine available market pathways (e.g., 510(k), De Novo, PMA)
    • If a 510(k), identify possible predicate devices.
    • Will the SaMD need clinical performance testing, and roughly what form this would take?
    • Identify key regulatory risks and ensure they’re inline with the business goals.
    • Determine any architectural design constraints that could reduce how much of the software is considered part of the device (per the 2020 Multiple Function Device Product FDA Guidance).
    • If the device is a series of modules will each module have it’s own IU statement? Will there be an overall software ‘Platform’ which serves as the user interface and which may perform some functions (i.e., image viewer, report generation)?
  4. Develop a Clinical Validation Strategy
    1. The exact scope of this will vary based on the device and may include Performance Testing Study, Multi-Reader Study if needed, Technical Performance Assessments, Standalone Testing, etc.
    • Determine if the product is a CADq (quantification), CADe, CADt, CADx, or CADp (prognostic) device.
    • Explore the data you already have available to ascertain if it can be reused for the study.
    • Work with you to tweak your device’s indications for use and marketing claims to make the clinical validation study significantly easier and faster without sacrificing too much marketing value.
    • Conduct a statistical power study to justify the anticipated sample size.
    • Design the standalone performance study design
    • Design the clinical performance study design if necessary
    • Provide a proposal for the cost necessary to conduct the study(ies)
  5. Write the pre-sub request, including
    • Meeting Purpose
    • Device Description
    • For each algorithm component:
      • Algorithm description and verification strategy
    • Standalone Performance Testing Plan
    • Clinical Performance Testing Plan
    • Training Data Description
      • Demographics, sample size, number of Institutions, qualification of the annotators
    • Validation Data Description
      • Demographics, sample size, number of Institutions, qualification of the annotators
    • Proposed Predicate Device
    • Proposed Indications and Intended Use
    • Predicate Device Comparison (for a 510(k))

For additional details about our process, you may take a look at our published resource “How to Document AI/ML Algorithms in FDA Presubmissions (Q-Sub)”. Note that the approach is continually evolving and may not follow this document exactly.

The primary deliverable of this phase is the pre-sub documents that are sent to FDA. We’ll also include a regulatory strategy document that includes most of the same information, as well as a few additional information that is not always shared with FDA:

# Why Innolitics? - **All we do is software as a medical device (SaMD) and AI as a medical device** since 2012 - **50+ SaMD and SiMD products** cleared through FDA - We have experience with all the flavors of AI enabled medical devices including CADq (quantification), CADe, CADx, CADt, and CADp (predictive) - **We have full time MDs, PhDs, software engineers, and regulatory experts** on staff - We are the only ones offering a **speed and certainty guarantee** ## We\'ve Done This Before ![](/img/services/Regulatory_Strategy_Q-Sub_and_BDD_in_4_Weeks-2a3bd5b7a75480d3bdfdcac8fea50aa3.png) ## What Our Clients Say
## **Case Studies**
## Testimonials
# Our Publications We are thought leaders in the AI/ML enabled medical device software space. Here are some of our [many articles and resources](https://innolitics.com/articles/):
# FAQs

How much does it cost?

Pricing depends on your device, timeline, and scope. Contact us for a custom quote.

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.

Can I publish a breakthrough device designation?

Yes! We have seen many companies receive funding and/or get acquired after getting a BDD. It is a positive market signal.

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, feel free to read our resources to seek guidance on your pathway.

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.

# Let's Go! In a 30-minute call, we\'ll assess if your device is a good fit for our program or alternative services and provide a clear path forward.
Let's Meet!