The FDA Breakthrough Device Designation was created in 2015 to expedite device access for life-threatening and debilitating diseases.
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What is the FDA Breakthrough Device Designation?
The FDA Breakthrough Device Designation is a formal identification by the US FDA that a device in development should be expedited for patient access because it has a reasonable chance of providing more effective treatment than the standard of care for the treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
To be granted breakthrough status, your device must also meet at least one of the following four secondary criteria:
- Represents Breakthrough Technology
- No Approved or Cleared Alternatives Exist
- Offers Significant Advantages over Existing Approved or Cleared Alternatives
- Device Availability is in the Best Interest of Patients
Once the FDA has designated your device as a breakthrough device, all future communications with the FDA related to that device should be identified with the Q-sub reference number assigned to your breakthrough request.
What are the benefits of receiving the designation?
The breakthrough designation helps the FDA identify new technology to focus on in order to expedite access to novel devices that will save lives and treat debilitating diseases. It takes the FDA longer to review these devices because these devices may raise novel scientific and regulatory issues. Therefore, the FDA prioritizes 510k and De Novo submissions for breakthrough devices over other 510k and De Novo submissions, and the FDA’s senior management is involved in the review process. The average review time for the seventeen 510k cleared breakthrough devices was 151 days. This may not seem like an expedited review, but the average review time for 510k cleared devices that require additional testing data is almost 270 days. The average review time for the twenty De Novo Classification Requests that were designated as breakthrough devices was 257 days. This represents a significant improvement when compared to the average De Novo Decision timeline of 338 days for 2019-2022.
Breakthrough Device Designation by the FDA also has a benefit with regard to reimbursement. Normally new technology is not covered by CMS for the first two years. Specifically, the Centers for Medicare and Medicaid Services (CMS) normally takes two years to establish qualification for public reimbursement coverage in the USA. In contrast, private insurers are inconsistent in their coverage because Medicare Administrative Contractor (MAC) is divided into 13 different US regions, each making independent coverage decisions on a case-by-case basis. When you receive Breakthrough Device Designation, you receive immediate coverage through CMS until traditional coverage takes effect. This interim coverage period gives your company the opportunity to establish the clinical benefits of your device so that you can apply for payment and coding to establish long-term reimbursement coverage.
Mechanisms of Expedited FDA Review
In addition to identifying breakthrough devices for priority review and involving the FDA’s senior management, the FDA also offers four other mechanisms for improving the review time. First, the FDA offers “Sprint discussions.” A “Sprint” discussion allows the FDA and the company to discuss a single topic and reach an agreement in a set time period (e.g., 45 days). The FDA provides an example of a Sprint discussion similar to a pre-submission meeting, but the overall timeline is half the duration of the FDA’s target MDUFA V decision goals.
The second mechanism for improving the review time is a Data Development Plan (DDP). Using this mechanism, the FDA will work with the company to finalize the non-clinical and clinical testing plans for the breakthrough device. This may include starting clinical testing earlier while deferring certain non-clinical testing.
The third mechanism for improving the review time is Clinical Protocol Agreement. In this scenario, the FDA will interactively review changes to clinical protocols rather than conducting a protocol acceptance review first. Therefore, the time required to review and approve a clinical protocol change is less, and the sponsor can complete their clinical studies in less time.
The fourth mechanism for improving the review time is a prioritized pre-submission review. If a company prefers to discuss multiple issues in one meeting rather than conducting Sprint discussions on single topics, then the FDA will prioritize pre-submission review. The prioritized pre-submission will be tracked as an interactive review with a shorter timeline than other pre-submission meeting requests.
How do you apply to the FDA for Breakthrough Designation?
To receive the designation, you must prepare a Breakthrough Device Designation request and submit it to the FDA Document Control Center (DCC) as an eCopy. The eCopy can be done via FedEx or through the new Customer Collaboration Portal (CCP) launched by the FDA in 2022. Your application could consist of a single document, but we recommend at least three documents: 1) a formal request outlining how your device meets the criteria for breakthrough designation, 2) a detailed device description, and 3) preliminary clinical data demonstrating the feasibility of your device delivering performance claimed in your request for designation. There are no user fees associated with the application for breakthrough designation, and you are not prevented from submitting other types of submissions in parallel with the breakthrough designation request, such as a pre-submission or investigational device exemption (IDE).
When should you apply to the FDA?
If the FDA denies an initial breakthrough designation request, the company may re-submit a request at a later date. Therefore, companies should submit requests as soon as they can provide preliminary clinical data to demonstrate the feasibility of the device’s claimed performance. Therefore, a breakthrough designation request would typically be submitted at the conclusion of an Early Feasibility Study (EFS), which allows a maximum of ten clinical subjects.
How many companies have received Breakthrough Designation from the FDA?
Since the start of the Breakthrough Designation program in 2015, the FDA has granted 693 devices Breakthrough Device Designation. CDRH, the device division of the FDA, granted 687, while CBER, the biologics division of the FDA, granted 6. The breakthrough designation, however, does not guarantee FDA market authorization. Only 54 of the breakthrough designations have resulted in market authorization so far. Two of the 54 devices were reviewed by CBER. Of the remaining 52 devices, 15 devices received 510k clearance, 17 De Novo Classification Requests were granted, and 20 PMAs were approved. Given the number of submissions received each year, only 10-15% of De Novo and PMA submissions are also Breakthrough Devices. In contrast, only about 0.1% of 510k submissions are also Breakthrough Devices.
