Consulting with FDA under the Pre-Sub

FDA' Breakthrough Devices Program

-by Dalia Givony-

Medical device manufacturer that develops a device that provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, and has a novel technology, might want to apply for FDA' Breakthrough Devices Program.

The Breakthrough Devices Program was established by FDA in 2015 with a goal to

provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review process.

To be eligible for the program devices must meet the following criteria:

First the device has to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
Second, the device must meet at least one of the following four 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

According to FDA guideline from Dec 2018 a company with a device that was found eligible for Breakthrough Devices Program could benefit from:

Interactive and timely communication with FDA
Pre/Post market balance of data collection- FDA may consider the amount and nature of data that may be collected in the postmarket setting, rather than premarket, and the extent of uncertainty that may be appropriate in the benefit-risk profile at the time of approval.

Efficient and flexible clinical study design- FDA intends to take steps to ensure that the design of clinical trials is as efficient and flexible as practicable, when scientifically appropriate.
Review team support – additional staff with subject matter expertise to review specific aspects of the submission; for example, by providing consultation on the disease or condition at issue or on a clinical study design.
Senior management engagement
Priority review - All submissions for device designated as Breakthrough Device will receive priority review and receive additional review resources, as needed.
Preapproval Inspection for PMA submission - FDA intends to expedite the review of manufacturing and quality system compliance for devices in the Breakthrough Devices Program.

A request for Breakthrough Device designation should be submitted as a “Designation Request for Breakthrough Device” Q-Submission, at any time prior to submitting premarket approval application (PMA), premarket notification (510(k) or De Novo classification request.

In order to benefit from the program, it is recommended to submit a request at an early stage, when preliminary clinical data can support the device' feasibility.

Companies can expect to receive FDA's decision to grant or deny the Breakthrough Device designation request within 60 calendar days of the FDA receiving the request.

Since the start of the Breakthrough Designation program in 2015 CDRH and CBER have granted 728 Breakthrough Device designations as of September 30, 2022,

Do you think your device might be eligible for Breakthrough Designation Program?