Initial Regulatory Assessment

This solution is for entrepreneurs and early-stage startups who are exploring bringing new medical device software onto the US market.

By the end of our process, you will understand

1. the current regulatory landscape,
2. the necessary steps for market entry, and
3. estimated timelines associated with these steps.

This consulting solution is designed to provide targeted support in de-risking the regulatory strategy within a constrained budget. To get the most value out of the engagement, you will need to put some time in. The solution includes interactive discussions with a seasoned regulatory professional and medical device software architect.

Our Process

Step 1. Information Gathering

Prior to the meeting, you’ll need to provide:

1. Business Goals in bringing SaMD to US Market
2. Marketing claims are being considered (must have and nice to have)
3. Device Description
4. Similar devices on the market, highlighting similarities or differences
5. Summary of Existing Software Code Development and Documentation Status
6. Up to 3 Functional or Intended Use Variations for Consideration
7. Other Regulatory Questions or Concerns
8. Other Software Development Questions or Concerns

We will provide access to our Medtech OS portal, where you’ll be able see descriptions of each of these items along with multiple examples.

Step 2. Initial Meeting

The Innolitics regulatory team will review your documents and will conduct preliminary research and regulatory pathway analysis to prepare for the following meeting:

Meeting Agenda:

1. You provide a brief overview of the meeting inputs
2. We’ll provide an overview of the regulatory space including:
   1. Potential product code(s) and regulations for the device/indications
   2. Regulatory pathways taken by the similar products
   3. Potential paths to market for the device/indications
   4. Key regulatory risks and hurdles
   5. Tests that may be required for regulatory submission
3. Discuss the implications and pros and cons of different choices in design or indications
4. Narrow down the favored pathway
5. Discuss other regulatory and software questions or concerns

Meeting Outputs:

1. Device Description & Feature List
2. Indications for Use
3. Preferred Regulatory Pathway including Design & Indications
4. Scheduled Regulatory Assessment Meeting (usually 1 week later)

Step 3. Documenting the Regulatory Assessment

The Innolitics consultant will use feedback from the initial meeting to document the regulatory assessment including the following items based on the preferred option discussed in the informational meeting:

• Device Description
• Likely Regulatory Path Description and Rationale (e.g., 510(k), De Novo, PMA, etc.)
• Indications and Intended Use Statement
• Identification of Potential Product Codes and Regulations
• Summary of Similar Devices and their Regulatory Paths
• Potential Predicate Devices (if 510(k))
• List of Relevant FDA Guidance Documents and Standards
• List of Tests that may be required
• Key Regulatory Risks (i.e., issues that may prevent getting the device to market, and how likely they are to occur)
• Cost-Benefit commentary relating to the other paths discussed (if applicable)

We may reach out with questions while during the regulatory assessment.

Step 4. Regulatory Assessment Meeting

In this step we’ll present our findings.

Meeting Agenda:

1. Innolitics Consultant provides an overview of the Regulatory Assessment
2. Discussion of the Assessment
3. Consultant provides a regulatory roadmap describing the FDA processes as applicable to the project regulatory pathway:
   1. 513(g)
   2. Pre-Submission
   3. Breakthrough Designation
   4. 510(k)
   5. De Novo
   6. PMA
4. Consultant provides high level information on submission documentation and the regulatory submission process logistics.
5. Q&A

Meeting Outputs:

1. A clear idea of a path to market for their device and the strategic insight to help make choices relating to the design and indications for their device to best achieve their compliance and marketing goals.
2. A high level understanding of the process and paperwork involved in preparing their regulatory submission.
3. An understanding for the submission logistics.
4. Your most pressing regulatory questions answered.

Step 5. Follow-Up Meetings & Support

Following the Regulatory Assessment Meeting, should you desire further discussions, we’ll remain available for follow-up meetings and support for one month. During this period, the client will be billed at our hourly rate for any additional assistance required.

Should the client wish to utilize additional Innolitics services or solutions, such as regulatory strategy development, pre-submission meeting support, or 510(k) submission consulting, a new Statement of Work will be created to outline and scope the continued efforts accordingly.​

Pricing

This service is offered at a discount for early stage startups, clinicians, or entrepreneurs. We don’t offer this service to larger companies or established medical device manufacturers.

Milestone	Price	Timeline
Contract Signing	$1000	N/A
Complete Regulatory Assessment Meeting	$1,500	1 - 2 Weeks
Follow-Up Calls/Support	Standard Hourly Rates	Up to 1 Month After

Top Regulatory Resources

Here are a few of the many articles we published on US FDA regulatory topics: