FDA Breakthrough Device Designation Request: Accelerated Pathway Guide
A medical device manufacturer approached Elexes with a very unique medical device. While the product had a lot of advantages over any other treatment option in the target clinical area, the manufacturer was unsure of how to get the product to the market in the least burdensome accelerated manner.
Elexes reviewed the product and since it was a unique product that addressed an unmet medical need Elexes suggested the medical device company to apply for a Breakthrough Device Designation often called the BDD application. When Elexes made the Company aware of BDD, they were very interested in learning more about this program and how they could be eligible for it. In order to facilitate the understanding Elexes held a Q&A session (see below).
Elexes has guided 20+ breakthrough device applications with FDA since 2021. As an RA Director or Founder, this guide ensures you confidently navigate Breakthrough designation.
Question - What Is FDA Breakthrough Device Designation?
Response
The breakthrough devices Program is intended for the manufacturers of certain medical devices, IVDs, or combination products that are believed to have the potential to provide more effective treatment or diagnosis of life-threatening diseases or irreversibly debilitating diseases or conditions. This includes the devices or combination products that are subject to Premarket Approval (PMA), Premarket Notification (510(k)), and De Novo submission.
However, this program is intended for or granted only to novel medical devices, IVDs, or combination products that involve novel technology which is nothing like the existing ones in the market.
Breakthrough Devices Program supersedes Expedited Access Pathway which was introduced by FDA in 2015, Innovation Pathway, and the Priority Review Program.
Question - What is the aim of this program?
Response
This program aims to pave a pathway for the manufacturers to speed up the development, assessment, and review of their innovative products with breakthrough technologies and to provide the patients with timely access to such innovative solutions without any compromise on safety and effectiveness.
Question - Who is eligible to participate in this program?
Response
In order for a manufacturer to be eligible to participate in the Breakthrough Device Program, their medical devices, IVDs or combination products must meet the following first criteria and one of the second criteria.
First Criterion: The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions
Second Criterion: The device also meets at least one of the following:
⦿ Represents Breakthrough Technology
⦿ Not Approved or Cleared Alternatives Exist
⦿ Offers Significant Advantages over Existing Approved or Cleared Alternatives
⦿ Device Availability is in the Best Interest of Patients
Question - What is the process?
Response
The Breakthrough Device Program has two stages.
Stage 1
⦿ During this stage, the manufacturer submits an application to the FDA. The application must explain how the device in question meets the criteria above along with the evidence to prove the claims if any.
⦿ The FDA will then review the application and reach a decision within 60 calendar days.
⦿ The FDA will request the manufacturer to provide additional information if required within 30 days.
Stage 2
⦿ During this stage the FDA works alongside the manufacturer to expedite the development process of the device and will also prioritize the review of the subsequent regulatory submissions and approvals.
Question - What are the benefits of this program?
Response
The Breakthrough Device Program offers many benefits to manufacturers with novel devices and technologies to expedite their market availability and accessibility. Some of the benefits are as follows:
⦿ Interactive Communication with the FDA which allows the manufacturer to interact with the FDA directly during the pre-market development and also during the submission process. This will also allow the manufacturer to improve the quality of the device to ensure its safety and efficacy.
⦿ Priority review by the FDA will speed up the approval process for the device (e.g. 510(k), PMAs).
⦿ Flexible clinical study design which allows the manufacturer to collect study data at the beginning of the post-market phase, provided there are no safety concerns. FDA will also allow the manufacturer to adapt the study design when the study is being conducted as well as during the approval process.
⦿ Dedicated and well-trained review teams will be allocated by the FDA.
⦿ Involvement of Senior FDA Management.
Question - How long does the FDA take to review the Breakthrough Designation request?
Response
FDA generally takes 60 calendar days from when the request is received to either grant or deny a Breakthrough Designation to the device. FDA may request for additional information to be submitted within 30 days.
If the manufacturer fails to provide FDA with the additional information requested within 30 days, it may result in denial of the Breakthrough Designation.
Would you like to apply for a Breakthrough Device?
Elexes is here to help you. Our dedicated team has years of experience in supporting our clients in the process of Breakthrough Device Designation submission. Please contact us at [email protected] or call +1 650-503-6615 to have us review, if your device will be eligible for a BDD and the corresponding next steps.
Breakthrough Device Submission Checklist
FAQs
What qualifies a device for FDA Breakthrough Designation?
Devices must provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions.
How long does FDA take to grant Breakthrough status?
The FDA typically reviews the request and responds within 60 days.
What documentation is required for a breakthrough request?
Provide: device description, indications/intended use, regulatory history (if any), explanation of how the device meets the statutory criteria, and supporting data. Use the format and templates recommended in FDA guidance.
Can breakthrough designation speed up market launch?
Yes, it enables prioritized FDA review and earlier patient access. With the correct alignment on the FDA sprint reviews and adequate manufacturer efforts, it can provide relatively faster market access.
What are post-approval commitments after breakthrough designation?
Manufacturers must commit to frequent, structured interactions with the FDA. They must dedicate regulatory resources to respond to FDA, including providing the clinical and non clinical data during feedback loops. Additionally, they must comply with post-market surveillance, reporting, and ongoing FDA Breakthrough Device Program requirements.
