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FDA Pathways for Breakthrough and Innovative Devices

Regulatory Strategy for Novel & Breakthrough Devices

Innovative devices face unique FDA challenges. From Breakthrough designation to De Novo pathways, success requires proactive planning, flexible evidence strategies, and early FDA engagement. Learn how to navigate uncertainty and accelerate patient access.

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Innovative medical devices – especially those addressing unmet needs or serious conditions – require a different regulatory playbook. The FDA recognizes this through programs like the Breakthrough Devices Program, which expedites development and review for game-changing technologies. Even devices that aren’t formally “Breakthrough” often face more uncertainty in the approval process. Crafting a regulatory strategy for novel and breakthrough devices means planning for extra FDA interaction, flexibility in evidence requirements, and often blazing a new trail on the regulatory pathway. 

Breakthrough Designation: Fast-Tracking Innovation

The Breakthrough Devices Program is FDA’s flagship for speeding up innovative devices that treat or diagnose life-threatening or irreversibly debilitating diseases[30]. If your device qualifies (it provides a more effective solution for a serious condition and meets other criteria), obtaining Breakthrough designation can significantly influence your strategy:

  • Dedicated FDA Attention:
    Once designated, a Breakthrough device gets increased communication with FDA experts through several program options. This may include sprint discussions on specific issues, regular check-ins, and senior management involvement. Plan to take full advantage – schedule frequent FDA touchpoints and be ready to pivot quickly based on feedback from these interactions.
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  • Priority Review & Flexibility:
    FDA prioritizes Breakthrough device submissions. The Agency may also apply flexible approaches, such as accepting less pre-market data (with rigorous post-market controls) or streamlining clinical requirements, given the device’s potential. Leverage this by negotiating what evidence is truly needed pre-market. For example, perhaps a smaller pivotal trial or use of an intermediate endpoint could suffice with a post-market study to confirm benefit. Be proactive in proposing reasonable approaches to balance timely patient access with assuring safety.
  • Early Issue Resolution:
    Novel technologies often lack clear precedents. The Breakthrough program’s interactive nature lets you address novel issues in real-time. If no standards or test methods exist for an aspect of your device, present a well-reasoned testing plan and discuss it in sprint meetings. Use these interactions to effectively co-create your device’s regulatory pathway with FDA’s guidance at each stage.
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Strategies for Other Novel Devices (Beyond Breakthrough)

Not every novel device is eligible for Breakthrough (e.g. it may address a less critical condition), but similar strategies apply:

  • Consider Safer Technologies (SteP):
    FDA’s SteP program is analogous to Breakthrough for devices that offer safety improvements for non-life-threatening conditions. If your innovative device is moderate-risk, SteP designation could provide more FDA feedback and a faster review.
  • Master the De Novo Pathway:
    Many novel devices without predicates go through De Novo classification. Tailor your strategy for De Novo: clearly document the device’s risk-benefit profile and be ready to propose appropriate special controls for risk mitigation. A successful De Novo essentially creates a new device type, so frame your submission to justify your device and establish a sensible regulatory framework for it. Engage FDA early (via Pre-Subs) to confirm your approach to demonstrating safety and effectiveness without a predicate.
  • Regulatory Science Advocacy:
    When blazing new trails, you may need to help FDA understand new science. This means educating and advocating – explaining why traditional methods might not fit and proposing credible alternatives backed by evidence. FDA is open to innovation, but you must make a compelling case for any novel testing methods, trial endpoints, or approval approaches.
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Planning for Uncertainty and Risk

By nature, novel and breakthrough devices carry more unknowns. Strategically:

  • Plan for Change:
    Anticipate that FDA might request extra data or impose post-market requirements – build time and resources for these into your plan so you’re not caught off guard. Also, stay alert to FDA signals (new guidances, advisory committee discussions, etc.) in your field. Regulatory expectations in cutting-edge areas can evolve quickly, so be ready to adjust your strategy if FDA’s thinking shifts during development.
  • Build Contingencies:
    If FDA feedback or early data reveal an issue, have a plan B. For example, if an initial clinical endpoint isn’t panning out, be prepared to discuss an alternate endpoint or additional analysis with FDA. Agility is key with novel devices – your strategy should be iterative, not set in stone.
  • Maintain Dialogue:
    For Breakthrough devices in particular, maintain a collaborative tone with FDA throughout development. Addressing concerns as they arise (rather than waiting for formal review) means fewer surprises. Many breakthrough sponsors find that by the time they submit their application, most major issues have been vetted, making final approval smoother.
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Conclusion

Novel and breakthrough devices are at the forefront of medical innovation – and navigating their regulatory journey requires flexibility, proactivity, and close FDA collaboration. The good news is FDA wants these devices to reach patients when they address serious unmet needs. Through programs like Breakthrough and a thoughtful approach to De Novo and other pathways, you can turn novelty from a hurdle into an advantage. The keys are to engage early, plan for various scenarios, and innovate not just in your product but in your regulatory strategy as well. ADBC CRO has supported multiple novel device developers, helping secure Breakthrough designations, guiding De Novo strategies, and crafting creative clinical plans. With the right approach, even uncharted regulatory waters can be successfully navigated – bringing groundbreaking devices to patients faster. 

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