Explaining the Breakthrough Devices Program

What Is the Breakthrough Devices Program?

The FDA breakthrough devices program is a voluntary program for certain medical devices and device-led combination products. Through the program, patients have timely access to the latest medical devices, meaning they get better, faster care and treatments for life-threatening or irreversibly debilitating diseases or conditions.

The goal of the program is to accelerate the development, assessment, and review of devices while still adhering to the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization. The breakthrough devices program replaces the Expedited Access Pathway (EAP) and Priority Review programs for medical devices. However, devices granted designation under the Expedited Access Pathway are also considered part of the program.

Benefits of the Breakthrough Devices Program

The breakthrough devices program is significantly beneficial if you’re developing a medical device that addresses a current unmet need in the healthcare industry. For certain types of medical devices, the program provides manufacturers with a streamlined process for gaining approval for premarket submissions through a wide variety of interactions with FDA experts, including workshops, guidance documents, and pre-submission meetings. Not only does the breakthrough devices program offer helpful feedback from the FDA, but medical device manufacturers can also expect a prioritized review of their submissions. With the breakthrough program, you can ensure your product reaches the market as quickly as possible.

Different FDA Breakthrough Devices

As of December 31, 2022, the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH), both governed by the FDA Intercenter Agreement, have granted 760 breakthrough device designations, including devices originally designated under the EAP program.

A few of the most recently approved FDA breakthrough devices include:

Sacroiliac Joint Fixation, an implanted orthopedic device that bridges both sides of the joint.
Alzheimer’s Disease (AD) Pathology Assessment Test, an In Vitro test that determines whether a patient being evaluated for AD will test positive or negative for amyloid plaques or neurofibrillary tangles measured by PET imaging agents.
Adjunctive Heart Failure Status Indicator, a device that analyzes patient data, such as echocardiographic images, and provides an output that indicates likelihood of the presence of heart failure.
External Upper Limb Tremor Stimulator, a device that’s placed externally on the upper limb and designed to aid in tremor symptom relief.
Oropharyngeal Electrical Stimulator, a device intended to treat swallowing dysfunction.
Transcutaneous Electrical Nerve Stimulator, a device intended to treat fibromyalgia symptoms.

Is My Device Eligible?

Your device is eligible for breakthrough device designation if it’s subject to premarket approval applications (PMAs), premarket notification (510(k)), or requests for De Novo designation and meets the following criteria:

The medical device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
The device also meets at least one of the following:
a. Represents breakthrough technology
b. No 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

When to Request a Breakthrough Device Designation

The best time to send a breakthrough device designation request is before sending your marketing submission, such as a premarket approval (PMA), premarket notification 510(k), or De Novo classification request. By submitting a device designation request prior to your marketing submission, you can take advantage of all the above benefits offered by the program before the review process begins.

Your request should include detailed information about your device, such as:

A brief summary of the device’s intended use and technology
A description of the potential benefits to patients
A discussion of how the device meets the criteria for breakthrough designation
Clinical data supporting the device’s safety and effectiveness

How to Request a Breakthrough Device Designation

To request a breakthrough device designation, you must submit a “Designation Request for Breakthrough Device” Q-Submission to the FDA. When submitting your request, make sure it’s the only one in the Q-Submission. Your designation decision may affect the feedback that the FDA provides on your other requests, so if you have other requests pending, you may want to wait until after the FDA makes a decision on your request waiting approval. If the FDA finds your device to be a good candidate for the program, you may receive a sponsor recommendation.

What to Include in a Request for a Breakthrough Devices Designation

The FDA recommends that your designation request include information that describes your device, the proposed indication for use, regulatory history, how your device meets the statutory criteria for a breakthrough device, and what type of marketing submission you plan to submit. In addition, all requests should include a discussion of the clinical benefits of the device and a comparison of the device to any existing, approved, or cleared alternatives.

To ensure your device is FDA-approved, it’s important to understand communication expectations during the submission process.

Learn More

Helping You Navigate the Breakthrough Device Designation Process

At Remington Medical, we understand the complexities of the breakthrough device designation process. As an experienced medical device manufacturer, we have the expertise and resources to help you navigate the process so you can get your product to market quickly and effectively. While the process can be complicated and time-consuming, our experienced medical device manufacturers are here to help guide you through each step, from determining your eligibility to submitting your application as your manufacturer of record. We’ll also help you prepare a clear, compelling argument as to why your device should qualify. Contact us today to learn more about our contract manufacturing services and how we can help you navigate the approval process.

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Explaining the Breakthrough Devices Program

What Is the Breakthrough Devices Program?

Benefits of the Breakthrough Devices Program

Different FDA Breakthrough Devices

Is My Device Eligible?

When to Request a Breakthrough Device Designation

How to Request a Breakthrough Device Designation

What to Include in a Request for a Breakthrough Devices Designation

Helping You Navigate the Breakthrough Device Designation Process

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