The Breakthrough Device Program: Part 1

Illustration of a rocket bursting through a wall

Welcome to our blog

Welcome to our blog, where we will try to clarify the obtuse announcements from FDA and CMS and cover other topics to biomedical firms. We hope you are able to take away some pearls in each of our posts. We will start with the recent FDA final guidance on the Breakthrough Device Program. This will be three segments, which will segue into reimbursement and clinical trial impacts.

What is the Breakthrough Device Program?

The US FDA recently published the final guidance for the Breakthrough Device Program. This program is for certain medical devices and device-led combination products that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program replaces the Expedited Access Pathway and Priority Review for medical devices.

Is my device eligible for this program?

Many manufacturers are wondering if their device is eligible for this program. Devices subject to premarket approval applications (PMAs), premarket notification (510(k)) or requests for De Novo designations are eligible for Breakthrough Device designation if they meet the following designation criteria.

Designation Criteria

The designation criteria, as defined in section 515B(b) of the FD&C Act (21 U.S.C. 360e-3(b)), are:

Provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions; and

  1. Represent breakthrough technologies;
  2. No approved or cleared alternative exist;
  3. Offer significant advantages over existing approved or cleared alternatives, including the potential, compared to existing approved alternatives, to reduce or eliminate the need to hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or
  4. Availability of which is in the best interest of patients.

Simply stated, devices must meet the first criterion and at least one of the sub-paragraphs of the second criterion in order to be granted Breakthrough Device designation.

Continue to Part 2: The Breakthrough Device Program: Part 2 - The First Criterion

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