Breakthrough Device Designation – FDA Fast-Track Pathway
Device Designation
The Breakthrough Device Designation is introduced by the US FDA to speed up the development, review, and approval of medical devices that can provide more effective treatment than the standard of care for the diagnosis or treatment of life-threatening or permanently debilitating human diseases or conditions so that patients can access them more quickly.
Medical Devices meeting the criteria below may qualify for Breakthrough Designation and be considered for FDA's priority review, speeding up their development and approval.
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Criteria
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Details
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1st Criteria: A device provides more effective treatment or diagnosis.
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The sponsor must show a reasonable expectation that the device could more effectively treat or diagnose the disease or condition listed in the suggested indications for use.
Literature or clinical data are two possible mechanisms for illustrating a realistic expectation of technical and clinical success.
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2nd Criteria: The device represents breakthrough technology.
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The device meets at least one of the following:
• The device represents a novel technology or novel application of an existing technology.
• The device has the potential to improve clinical outcomes in the areas of diagnosis, treatment (including treatment monitoring), cure, mitigation, or prevention of life-threatening or irreversibly debilitating diseases or conditions.
Example — A transcatheter heart valve that is delivered transcutaneous and does not require open heart surgery, thereby decreasing the risks of the procedure. This breakthrough technology has the potential to provide a clinically meaningful advantage in a patient population with few options.
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No approved or cleared alternative exists.
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If no alternative exists in the market for the treatment or diagnosis of life-threatening diseases.
Example — An ablation catheter that offers the potential ability to treat atrial fibrillation. Catheters were approved for the treatment of atrial flutter, and there was no legally marketed ablation catheter indicated for the treatment of atrial fibrillation. Therefore, at the time of review, the ablation catheter met the criteria for "no approved or cleared alternative."
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The device offers significant advantages over existing approved or cleared alternatives.
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The FDA determines if a device is significantly better than current devices in the market based on whether it can lower hospitalization rates, enhance patient quality of life, help patients control their own care, or provide long-term clinical efficiency.
Example — A product intended to treat a life-threatening or irreversibly debilitating disease or condition that does not have a serious adverse effect associated with an available product for treating this disease/condition.
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Device availability is in the best interest of patients.
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This criterion refers to devices that are made to address severe malfunctions in crucial parts, offer extra advantages like better patient engagement, deal with new public health issues like device shortages or emergencies, or demand a high risk of patient morbidity.
Example — An insulin pump that features a new mechanism to detect and respond to low blood glucose.
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How to Request for Breakthrough Device Designation
One can request Breakthrough Device designation via Pre-Submission program by submitting a Designation Request for Breakthrough Device, Q Submission or electronic copy of Q Submission can be sent online through the CDRH Customer Collaboration Portal.
What Should Be Included in the Designation Request:
- Information to describe the device
- The proposed indication for use
- Regulatory history
- How your device meets the statutory criteria for a Breakthrough Device
- What type of marketing submission you plan to submit to the FDA for your Device
Once your device has been identified by the FDA as a breakthrough device, the Q-sub reference number associated with your breakthrough request should be used in all subsequent communications with the FDA regarding that device.
Within 60 calendar days, the FDA will decide whether to designate a device as a breakthrough; sponsors are usually contacted by Day 30 to request further details. The request could be denied if there is not enough timely information.
There are no user fees associated with the application for breakthrough designation.
Examples of Devices Which Received Breakthrough Device Designation:
The below table indicates that if a device qualifies for Breakthrough Designation, it doesn't mean its submission pathway is by default DeNovo.
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Device Name
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Manufacturer
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Breakthrough Designation Date
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FDA Regulatory Pathway
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Esprit Btk Everolimus Eluting Resorbable Scaffold System
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Abbott Medical
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26/04/2024
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Pma
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Rho
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16 Bit, Inc.
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09/04/2024
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DeNovo
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I-Stat Tbi Cartridge With The I-Stat Alinity System
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Abbott Point Of Care.
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27/03/2024
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510(k)
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