FDA Breakthrough Devices Program: Eligibility, Designation Request and Benefits

The Breakthrough Devices Program is FDA’s voluntary program for devices that offer a more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. It does not change the evidence standard for marketing. What it changes is the way you work with FDA: more interaction during development, and prioritised review of your marketing submission. This guide explains who is eligible, how to request designation, what the program gives you and what it does not.

Eligibility

A device qualifies when it meets the first criterion and at least one of the other four:

1. It provides for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition (required).
2. It represents breakthrough technology.
3. There are no approved or cleared alternatives.
4. It offers significant advantages over existing approved or cleared alternatives.
5. Its availability is in the best interest of patients.

Where the technology is incremental or alternatives are well established, the request is likely to fail. Be specific about the clinical problem, the patient population and why existing options fall short.

What designation gives you

• Interactive communication with FDA experts during the premarket review.
• Prioritised review of the marketing submission, and of future Q-Submissions and IDE applications.
• Sprint discussions, focused sessions to resolve a specific issue in a short time.
• Data development plan discussions, which help you agree how evidence will be generated before and after marketing.
• Clinical protocol agreement requests for pivotal studies.
• For many sponsors, an added signal to investors, hospitals and payers. Treat it as a signal, not a guarantee.

How to request designation

1. Prepare the request. Include the device description, proposed indications for use, regulatory history, how each criterion is met with supporting evidence, and the planned submission type.
2. Submit it as a Q-Submission of the “Designation Request for Breakthrough Device” type, before the marketing submission. The request should be the only item in that submission.
3. Respond fast to questions. FDA generally asks for missing information within about 30 days, and slow responses can lead to a denial.
4. Receive the decision letter, which FDA aims to send within 60 calendar days.
5. Plan the interaction. After designation, ask for sprint or data development discussions as your plan requires. See Q-Submission meetings.

Related FDA programs

• Total Product Life Cycle Advisory Program (TAP): an FDA program that connects device developers with FDA, and with other stakeholders such as payers, early in development. Check FDA’s current enrolment rules and eligible device areas.
• Safer Technologies Program (STeP): a similar program for devices that are significantly safer than alternatives for non-life-threatening conditions.
• Early feasibility studies: IDE studies for early clinical evaluation. See IDE and device clinical studies.

What designation does not do

• It does not waive the statutory standard for PMA, 510(k) or De Novo. See PMA, 510(k) and De Novo.
• It does not remove the need for manufacturing quality and a design control file.
• It does not guarantee coverage or payment. Plan for reimbursement separately.
• It does not apply outside the US. Other regulators have their own programs.

Common mistakes

• Describing the benefit in general terms rather than comparing with the current standard of care.
• Asking for designation for a condition that does not meet the life-threatening or irreversibly debilitating test.
• Requesting designation too late, after the main design and evidence decisions are made.
• Not using the program’s interaction options after designation.
• Assuming that designation will speed up manufacturing readiness.

Frequently asked questions

Is designation public?

Before marketing authorisation, FDA generally does not disclose a pending or decided request unless the sponsor does so.

Does the program apply to software and AI?

It can, if the software is a device that meets the criteria. See AI-enabled devices and PCCP.

Can I apply more than once?

You can submit a new request if the facts or the evidence change. Address the reasons for the earlier denial.

FDA programs, guidance and statistics change. Confirm current requirements on FDA’s Breakthrough Devices Program page and with your regulatory advisers.

Related reading

• US FDA medical device regulations: the wider framework.
• FDA PMA guide: the pathway many breakthrough devices use.
• Q-Submission meetings: how to ask FDA for feedback.
• Regulatory strategy for US and EU market entry: align programs with your overall plan.

Talk to the AptSkill team

Planning a breakthrough designation request or FDA strategy? Send us your device type and goal.