FDA’s NEW Final Guidance on the Breakthrough Devices Program

Oct 4, 2023 | News |

FDA’s NEW Final Guidance on the Breakthrough Devices ProgramOn September 15th, 2023, the FDA issued an updated final guidance on the Breakthrough Devices Program. As established by section 515B of the Federal Food, Drug, and Cosmetic Act, the Breakthrough Devices Program is intended to expedite the development and review of medical devices which provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program aims to provide patients and healthcare providers with timely access to safe and effective medical devices and device-led combination products of public health importance. The Breakthrough Devices Program supersedes the Expedited Access Pathway (EAP) and Priority Review Program, which were similarly launched to expedite the review of breakthrough technologies.

This final guidance identifies the policies and procedures that the FDA intends to use to implement the Breakthrough Devices Program. Recent updates to this guidance extend program eligibility to medical devices that address health care disparities as well as non-addictive products designed to treat pain or addiction. The updated guidance also clarifies the FDA’s most current interpretation of Breakthrough Device designation criteria and outlines a procedure for the disclosure of Breakthrough status following marketing authorization.

Guidance Content

The final guidance offers a process-oriented framework for the implementation of the Breakthrough Devices Program. Sponsors may utilize this guidance to gain insight into relevant qualification criteria, designation request procedures, and program features.

Designation Request

To qualify for entry into the Breakthrough Devices Program, a device must meet established designation criteria. The first criterion asserts that the device must “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease.” To evaluate whether a device provides “more effective” treatment or diagnosis mechanisms, the FDA intends to consider the totality of available information about a device, including the anticipated clinical impact as well as the risks and benefits of the device relative to standard of care (SOC) alternatives. Device sponsors should consider the intended use of the device, its technology and features, and available SOC alternatives to determine the level and type of evidence needed to demonstrate improved efficacy. In the latest revision, the FDA recognizes a disease or condition as “life-threatening” if “the likelihood of death is high unless the course of the disease is interrupted.” Similarly, the FDA’s interpretation of “irreversibly debilitating” is based upon several factors including survival, day-to-day functioning, and the likelihood that the disease or condition will progress to a more serious form if left untreated.

In addition to meeting this primary criterion, the device must also meet one of the following secondary criteria:

  • The device represents a breakthrough technology
  • No approved or cleared alternatives exist relative to the device
  • The device offers significant advantages over existing approved or cleared alternatives
  • Device availability is in the best interest of patients

For each of these secondary criteria, the updated guidance provides in-depth examples to further clarify the FDA’s intended interpretation of the outlined criteria. Devices that meet the first criterion and at least one of the secondary criteria are eligible for Breakthrough Devices designation.

A request for Breakthrough Device designation should be submitted as a “Designation Request for Breakthrough Device” Q-Submission. The request should include a device description, the proposed indication for use, relevant regulatory history, the planned marketing application, and justifications as to how the device meets the designation criteria. All designation requests should be submitted prior to the submission of a marketing application (PMA, 510(k), or De Novo request). Requests obtained within or after a marketing application will not be reviewed.

Program Principles

The FDA has a 7-step implementation plan intended to expedite the authorization of Breakthrough devices. These include:

  1. Interactive and Timely Communication – This principle is intended to support the timely submission of IDEs, 510(k)s, De Novo requests, PMAs, and/or PMA supplements. Communication between the FDA and sponsor will include discussion of goals and timelines, the use of “track changes”, and summary tables to document interactions.
  2. Pre/Postmarket Balance of Data Collection – When scientifically appropriate, the FDA will rely on postmarket data collection, rather than premarket, to review a device. While dependence on postmarket data may increase the level of uncertainty associated with the device’s benefit-risk profile at the time of its approval, this approach will prevent the delay of device availability.
  3. Efficient and Flexible Clinical Study Design – Based on this program principle, the FDA will “take steps to ensure that the design of clinical trials is as efficient and flexible as practicable.”
  4. Review Team Support – For each Breakthrough Device submission, the FDA will assign a qualified review team to lead the scientific and regulatory review of the submission.
  5. Senior Management Engagement – This principle asserts that senior management will be involved in the review of Breakthrough Device submissions to ensure the consistent application of Program principles and timely resolution of disputes.
  6. Priority Review – All market submissions associated with a designated Breakthrough device will be placed at the top of the queue and extra resources will be allowed to ensure the timely review of these applications. Review times may take longer due to the risk these devices may contain, which is why priority review is deemed necessary.
  7. Manufacturing Considerations for PMA Submissions – In order to qualify a device must be in conformance with Quality System regulation 21 CFR part 820 and must submit information in a PMA in conformance with requirements under section 515(c)(1)(C) of the FD&C Act (21 U.S.C. 361e(c)1(C)) and 21 CFR 814.20(b)(4)(v). Breakthrough Devices reviews and/or manufacturing and quality systems compliance will be expedited by the FDA.

Program Features

In addition to these FDA-led implementation steps, sponsors of Breakthrough devices have the option to request feedback from the FDA prior to submitting a marketing application for the device. An example of this would be “sprint” discussions, which have the goal of “reaching mutual agreement on a specific topic within a set time period”. The guidance document outlines parameters for these discussions to ensure that these interactions are efficient and mutually beneficial. Sponsors may also elect to pursue a Data Development Plan (DDP) in coordination with the FDA. This Program feature aims to expedite device assessment by outlining data collection expectations for the entire product lifecycle. Similarly, the Clinical Protocol Agreement is another Program feature which enables the collaborative development of clinical protocols. Once a clinical protocol agreement is achieved between the device sponsor and the FDA, the FDA will issue a letter of documentation.

Sponsors may also choose to submit a Pre-Submission in order to work with the FDA on multiple subjects. Furthermore, the device sponsor and FDA may agree to the exchange of regular status updates as a mechanism for feedback. These status updates are intended to discuss general progress of the project and identify potential hurdles on a broad scope and, thus, provide an adequate alternative to the detail-oriented “sprint” discussion approach.

Call to Action

For those interested in learning more on the Breakthrough Devices Program, the FDA is hosting a webinar to discuss this specific guidance. During this webinar, the FDA plans to discuss the updates made to the final guidance, share how the program can help advance health equity, and answer any outstanding questions.

Webinar Information

Webinar – Breakthrough Devices Updated Final Guidance

Date: November 14, 2023

Time: 1 – 2 PM EST

Link to the FDA website for more information: Webinar – Breakthrough Devices Program Updated Final Guidance – 11/14/2023 | FDA

Do you have a medical device that meets the designation criteria for a Breakthrough device? We can help you navigate the process. Contact MEDIcept today for help at sales@medicept.com.


Health, Center for Devices and Radiological. “Breakthrough Devices Program.” FDA, Sept. 2023. www.fda.gov, https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program.

—. “CDRH Issues Updated Final Guidance on Breakthrough Devices Program.” FDA, Sept. 2023. www.fda.gov, https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-issues-updated-final-guidance-breakthrough-devices-program.

US Food and Drug Administration. “Guidance for Industry: Breakthrough Devices Program.” FDA, Sept. 2023. Zotero, https://www.fda.gov/media/162413/download.

Abby Rieck and CJ Stukel – Associate Medical Device Consultants