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FDA Pathway Identification

Understand Your U.S. Regulatory Path
Before You Invest in the Wrong Direction
Navigating FDA regulations is one of the biggest hurdles for health tech companies entering the U.S. market. Choosing the wrong regulatory pathway can delay market entry, increase costs, or even block your product entirely. Our FDA Pathway Identification package helps you clarify the right regulatory path for your product and plan your next steps with confidence.

How It Works:​

1. Schedule a Free Discovery Call here

  • Meet with us to discuss your product, regulatory questions, and U.S. market ambitions.
  • We'll use this call to assess if you're ready for a formal FDA pathway analysis and clarify what’s needed to move forward.
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2. Receive Your Quote
  • We review your information and send a tailored quote based on your company’s needs.
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3.  Formal Assessment
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  • You’ll be asked to provide the following documents:
    • Product description
    • Technical specifications
    • Intended indication(s) for use
    • Marketing materials
    • (Optional) Clinical trial design, if applicable
    • (Optional) Predicate device similar functionality
 
  • What you'll receive (in 2–3 weeks):
    • Identification of the most appropriate FDA pathway (e.g. 510(k), De Novo, PMA)
    • Predicate device analysis
    • High-level regulatory timeline
    • Key considerations based on your product scope​

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​​​​Who It’s For
  • Digital health and medical device companies preparing for U.S. market access
  • Teams that need clarity on regulatory strategy before investing in development or trial
  • Executives looking to plan timelines, costs, and partnerships with confidence

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Why It Matters
  • Avoid costly delays or missteps by choosing the wrong regulatory pathway
  • Gain a clear roadmap for FDA submission tailored to your product
  • Build confidence with investors, partners, and internal stakeholders
  • Align product development, marketing, and clinical plans with U.S. regulations
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Why Work With Us
 
This package is delivered through Rakesh Lal, a seasoned expert in medical device product development and FDA regulations.​
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He has a thorough understanding of software and AI applications in healthcare, cybersecurity, risk management, and bench and clinical validation.​By working with Rakesh, your team gains direct access to practical, actionable regulatory guidance, ensuring your product is positioned correctly for the U.S. market while minimizing risk and avoiding costly missteps.
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Unsure of your FDA pathway? Book a call.
With over 20 years of experience spanning Fortune 500 companies and startups, Rakesh specializes in digital health, wearable technology, software, and AI in healthcare.
 
He has contributed to the development of innovative medical products across cardiology, neurology, and other specialties, filing numerous 510(k) applications for startups with novel SaMD and biosensor technologies, including Empatica, Biofourmis, MC10, and Happy Ring.​
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