U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Medical Devices News and Events
  4. CDRH Issues Updated Final Guidance on Breakthrough Devices Program
  1. Medical Devices News and Events

CDRH Issues Updated Final Guidance on Breakthrough Devices Program

Sept 14, 2023

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health 

Advancements in science and technology offer extraordinary opportunities to develop innovative medical products that can save lives and lead to better diagnostics, better treatments, and better care for patients. The FDA is committed to advancing the public health by helping to bring innovative technologies to market and assuring that medical devices already on the market continue to be safe and effective.

The Breakthrough Devices Program reflects this commitment and the benefits of extensive engagement with industry as a means of bringing innovative products to patients in need. Launched in 2015, the program has expanded significantly and far exceeded expectations for Breakthrough Device designation requests and authorization volumes. As of June 30, 2023, CDRH has granted Breakthrough Device designation to 831 devices and granted marketing authorization to 77 devices with Breakthrough Device designation. These devices represent a wide range of intended uses and span regulatory pathways, highlighting the influence of this program throughout the Center.  

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Breakthrough Devices must meet the FDA’s rigorous standards for device safety and effectiveness to be authorized for marketing. 

Breakthrough Devices Updated Guidance

Today, the FDA issued an updated final guidance for the Breakthrough Devices Program from the draft guidance issued on October 20, 2022, Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. This final guidance is intended to help the FDA and our customers leverage the interactive nature of the Breakthrough Devices Program to further advance health equity. 

The guidance update reflects CDRH’s commitment to providing patients and health care providers with timely access to high-quality, safe and effective medical devices of public health importance. The updates are intended to clarify how the Breakthrough Devices Program applies to certain innovative medical devices that may address health inequities, aligning with CDRH’s Strategic Priority to Advance Health Equity. In addition, consistent with our obligations under the SUPPORT Act, the updates clarify that the Breakthrough Devices Program may be available for certain non-addictive medical products to treat pain or addiction (FD&C Act section 515B (21 U.S.C. 360e-3)).

The final guidance explains how CDRH will consider technologies and device features that may help to address health and health care disparities and promote health equity by providing more effective treatment or diagnosis in various populations that exhibit health care disparities for Breakthrough Device designation. The updates also provide sponsors with references to resources on the evaluation and reporting of various health equity data points within medical device clinical studies.

In addition, this guidance clarifies the FDA’s current interpretation of the Breakthrough Device designation criteria. In particular, the update explains that the FDA’s interpretation of “more effective” is based upon the totality of available information about the device, including the potential for the device to make a clinically meaningful impact and the risks and benefits compared to standard of care. The final guidance also explains that we may consider improved accessibility of a device when evaluating if it could meet the first breakthrough criterion. Finally, the update clarifies how the FDA discloses the Breakthrough status of designated devices once they receive marketing authorization.

Other CDRH programs also support the development, evaluation, and premarket review of Breakthrough Devices.

Regulatory Science

CDRH Regulatory Science Tools (RSTs) are used across the whole spectrum of devices. Many of the Breakthrough Devices that have received marketing authorization have used or referenced a tool from our regulatory science program. Some recent examples include: 

  • The virtual family RST, a set of anatomically correct whole body MR datasets (see references here and here), have been used over 450 times in premarket review and cited or referenced over 850 times.
  • A recent statistical model used to analyze, size, and simulate multi-reader multi-case (MRMC) reader studies, known as iMRMC, has been used in 62 premarket submissions covering 14 different product codes across 4 of the 8 OHTs.
  • Our additive manufacturing guidance has facilitated increased innovation in the use of 3D printing, which has been used on average 90 times per year across 30 product codes and 6 OHTs.

TAP Pilot

Starting in 2023, CDRH launched the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. A key goal of the TAP Pilot is to improve various aspects of medical device development and to increase the predictability and reduce the time from concept to commercialization, in part, by facilitating robust engagement early in the process with the FDA, industry and key stakeholders. TAP builds on the lessons learned from the Breakthrough Devices and Early Feasibility Studies Programs as well as the COVID-19 pandemic. 

TAP is a voluntary program intended to de-risk the medical device valley of death by providing industry with earlier and more frequent interactions with CDRH, more strategic input from patients, health care providers and payers, and proactive, strategic advice from CDRH to spur greater and more rapid development of high-quality, safe, effective, and innovative medical devices that are important to public health. The TAP Pilot is one of the commitments agreed to between the FDA and industry as part of the MDUFA reauthorization. For more information, see the MDUFA V commitment letter, MDUFA Performance Goals And Procedures, Fiscal Years 2023 Through 2027.  

In addition, by facilitating coordination of earlier, solutions-oriented input from patients, health care providers, and payers, the TAP Pilot can help developers better address patient needs and anticipate coding, coverage, reimbursement, and market adoption considerations. That input can be of significant value throughout device design and development, during clinical trials, and even when rolling out devices post-authorization. 
Over the course of MDUFA V, the TAP Pilot will first focus on CDRH-designated breakthrough devices. You can find the latest information on the TAP Pilot here

Next Steps

On Tuesday, November 14, 2023, at 1 p.m. ET the FDA will host a webinar for the medical device industry and others interested in learning more about the updated final guidance.

Related Information:

Back to Top