How to choose the right regulatory pathway for your Medical Devices in FDA: 510(k), De Novo, or PMA

Launching medical devices in the U.S. market requires a critical strategic decision: choosing the correct regulatory pathway with the FDA. This decision will significantly impact timing, costs, and commercial viability. In this post, we explain when it’s most appropriate to use the 510(k), De Novo, or PMA route and how regulatory consulting from Sanrubio, LLC can help you make the correct decision.

How to Choose the Right Regulatory Pathway for Your Medical Devices: 510(k), De Novo, or PMA

What are the main FDA Medical Device regulatory pathways?

• 510(k): Premarket notification that requires demonstrating “substantial equivalence” to a legally marketed predicate device.

• De Novo: Pathway for novel devices without a predicate, based on reasonable assurance of safety and effectiveness.

• PMA (Premarket Approval): The most rigorous route for high-risk devices, requiring robust clinical evidence.

Comparing the Pathways: When to use each

Pathway	When It’s Appropriate	Advantages	Disadvantages
510(k)	Lower-to-moderate risk devices with an existing predicate	Faster process, lower cost	Not suitable for highly novel devices without a predicate
De Novo	Novel devices with no clear predicate	Creates a new regulatory category; can become a predicate for future 510(k)s	May require clinical data; mandatory eSTAR template from 2025
PMA	High-risk devices (e.g., implants, life-sustaining)	High regulatory assurance; market credibility	Expensive, long timelines, clinical trial burden

Key factors to consider in choosing the regulatory route

When deciding, you can consider:

• Risk Assessment: What class (I, II, III) do the devices fall into based on intended use and risk?

• Predicate Device: Is there a legally marketed device with similar intended use and technology?

• Cost & Timing: 

  • 510(k): Typically the fastest and least expensive pathway; review timelines are usually around 90 days, with relatively low submission costs.

  • De Novo: Longer and more expensive than 510(k) due to the detailed analysis of safety and effectiveness; average review times range from 6 to 12 months, with intermediate costs depending on device complexity and the need for clinical data.

  • PMA: The most rigorous and costly pathway; review can take 12 to 18 months or more, with costs including submission fees, extensive clinical studies, trials, and comprehensive technical documentation.

• Use of eSTAR:

  • For 510(k): mandatory since 2023, unless exempt.

  • For De Novo: mandatory since 2025, with some waivers.

• Commercial Strategy: A successful De Novo can establish a new predicate for future devices.

How Regulatory Consulting can help you

• Conduct early regulatory assessment to choose the best pathway.

• Facilitate Pre‑Submission meetings with FDA to clarify expectations.

• Prepare the technical file (bench, clinical, labeling, risk analysis, substantial equivalent discussion, etc).

• Manage submissions using eSTAR, minimizing administrative risk.

• Build a realistic timeline for regulatory approval or authorization.

• Information about post-approval obligations: vigilance, reporting, inspections.

Conclusion

Choosing the right FDA regulatory pathway: 510(k), De Novo, or PMA, is a strategic decision that directly affects the success, timing, and cost of bringing medical devices to market. A specialized regulatory consulting partner like Sanrubio, LLC can help us assess options, prepare strong submissions, and navigate FDA requirements more efficiently.

Ensure Compliance with Sanrubio, LLC

At Sanrubio, LLC, strategically supporting manufacturers from the U.S., Latin America, Europe, and Asia, we offer:

• Medical Device Establishment Registration Renewal

• Personalized regulatory advice: from Pre-Submission design to 510(k) submission (Pre-market notification), De Novo or Breakthrough Devices submission.

• Strategic location: in Miami, key hub for foreign manufacturers entering the U.S. market.

• Free initial consultancy: analyze your case with us and optimize your regulatory strategy.

  
  

Ready to bring your Medical Devices to the U.S. market?

Contact us for a free personalized consult and move ahead with confidence in your regulatory journey.

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