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).  

Question – What is a Breakthrough Devices Program?

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 DeNovo 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.

  1. First Criterion – The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or condition
  2. Second Criterion – The device also meets at least one of the following:

a. Represents Breakthrough Technology

b. Not Approved or Cleared Alternatives Exist

c. Offers Significant Advantages over Existing Approved or Cleared Alternatives

d. 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:

  1. 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.
  2. Priority review by the FDA will speed up the approval process for the device (e.g. 510(k), PMAs).
  3. 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.
  4. Dedicated and well-trained review teams will be allocated by the FDA.
  5. Involvement of Senior FDA Management.  

Question – When a Breakthrough Designation is requested for a device?

Response – The Breakthrough Designation for a device can be requested at any time before sending the marketing submission such as PMA, 510(k), and DeNovo request to the FDA.

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 jennifer@elexes.com or call +1 650-503-6615 to have us review, if your device will be eligible for a BDD and the corresponding next steps.

#elexes #healthcare #breakthrough #device #medicaldevices #bdd #regulatoryconsultant #quality #fda

Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

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