FDA’s Breakthrough Device Designation, Expediting Your Pathway to Market

by: Stephen Tyrpak  – Operations MD, US & Canada; Executive Consultant @ PQE Group

In 2015 the US congress passed legislation to formally create Breakthrough Device Designation. The program was created to help expedite breakthrough technologies that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The ultimate goal of this program is to provide patients and healthcare providers with timely access to these medical devices by speeding up their development, assessment and review. Once admitted, the program provides the sponsor with expedited review and a more interactive experience with the agency. Breakthrough Device is NOT a market notification and does not give the sponsor the ability or right to distribute their device in the US.

The eligibility of Breakthrough Device Designation is based on a two criterion approach. For a sponsor’s device to be considered for the program it must fulfill criteria one, which is, the device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. The device must also satisfy at least one of the second criteria which are: a. Represents Breakthrough Technology, b. No Approved or Cleared Alternatives Exist, c. Offers Significant Advantages over Existing Approved or Cleared Alternatives, or d. Device Availability is in the Best Interest of Patients.

Breakthrough Device Program Benefits

Being accepted into the Breakthrough Device Program will not only speed up your communications, it will also allow for unique communication methods that help the sponsor optimize their interactions with the agency. These unique communications methods are: Sprint discussion, data development plan, clinical protocol agreement and an Interaction for Designated Breakthrough Device Designation Q-Submission. Although each of these methods is different, they all provide the sponsor a more interactive relationship with the FDA review team. The value to this is that most times, with a breakthrough technology, new testing or assessments are required. Additional feedback from the agency before you perform the testing can help ensure that the testing will satisfy their requirements to prove that your product is substantially equivalent or safe and effective. This saves both time and money.

In addition to interactive and timely communications, Breakthrough Device Program also provides sponsors with pre & post-market balance of data collection, efficient and flexible clinical study design, review team support, senior management engagement and priority review. These additional benefits have helped provide a layer of confidence that the least burdensome approach will always be required by the FDA.

In addition to regulatory support, Breakthrough Device Designation has provided substantial benefit to the US reimbursement for these novel technologies. Being accepted into Breakthrough Device Designation makes applying for New Technology add on payment (NTAP) and Transitional Pass-Through Payment for New Category of Device easier. These programs allow new technologies to receive additional reimbursement in the inpatient or outpatient settings. For NTAP, CMS removes the requirements to prove that your technology is new and also removes the requirement to provide data to support “substantial clinical improvement.” For the Transitional Pass-Through Payment for New Category of Device, CMS removes the requirement to provide data to support “substantial clinical improvement.” Having this reimbursement increases the reach of the potential patients you will be able to help by allowing more hospitals and outpatient settings the opportunity to use your product.

When Should I Apply?

A common question for Breakthrough Device Designation is “When should I apply?” The answer is almost always, “as soon as possible.” The sooner you are accepted into the program, the sooner you can benefit from it. It is recommended that some baseline studies be performed and their reports submitted to the agency for review with your application to support your claims but other than that, if you are 7 years or 2 months away from your market application, you should consider applying to the Breakthrough Device Program

Do you believe you have a Breakthrough Device?

If you want additional information on how PQE Group can help support your application and optimization of the program and its benefits, get in touch with us

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