The Food and Drug Administration (FDA) has published guidance on the Breakthrough Devices Program, a special framework for medical devices intended to diagnose and treat severe diseases and life-threatening conditions. 

The document constitutes a final version of the draft guidance published by the Agency earlier in October 2017. Due to its legal nature, the present guidance does not introduce any mandatory requirements the industry representatives shall follow but provides additional clarifications and recommendations instead. The FDA also mentions that an alternative approach may be applied, providing that it complies with the current legislation and has been agreed with the regulating authority in advance. 

Regulatory Background 

The Breakthrough Devices Program described herein is actually based on the provisions of the Federal Food,  Drug, and Cosmetic (FD&C) Act – the US key act in the sphere of healthcare products. The scope of the program covers certain medical devices and device-led combination products subject to review under premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request frameworks. The program is intended to expand the availability of medical devices. Actually, it replaces the Expedited Access Pathway (EAP) introduced by the FDA earlier in 2015, and the Priority Review Program. As it is stated by the Agency, the medical devices compliant with the EAP are deemed eligible under the Breakthrough Devices Program.

Moreover, the Breakthrough Devices Program serves as a basis for a Safer Technologies Program – a new framework for certain medical devices and combination products intended to treat and diagnose non-life-threatening diseases that employ the same principles and approaches. 

According to the present FDA guidance, the Breakthrough Devices Program is composed of two steps:
Designation Request – the interested party submits the appropriate application to the regulating authority; and
Prioritized review of the submission related to the medical device – the FDA allocates additional resources and assists the applicant in expediting the development of the medical device in question.

Thus, the Breakthrough Devices Program is intended to improve and enhance the effectiveness of communications between the interested party (e.g. a medical device manufacturer), and the regulating authority in order to reduce the time necessary to place a novel medical device on the market and make it available for healthcare professionals and patients due to the important role the device should play in addressing severe diseases and conditions. From the Agency’s standpoint, the aforementioned approach is used by the FDA to prioritize the allocation of review resources and focus on the medical devices that are the most important in terms of public health.

Breakthrough Devices Program Principles in Detail 

The present FDA guidance describes in detail the main principles the Breakthrough Devices Program is based on, and the approaches it provides to streamline the review process, as well as other regulatory procedures associated thereto. 

  1. Interactive and Timely Communications. First of all, the FDA emphasizes the importance of effective communications between the applicant and the regulating authority. In particular, the Agency would take all the steps necessary to accelerate the review of the appropriate submission, while the applicant shall provide the regulating authority with all the information necessary to assess the request, and also to provide any additional documents or clarifications the FDA may require within the shortest period of time. As part of this approach, the Agency would also assign special staff members for direct communications with the particular applicant. Since most of the medical devices subject to review under the Breakthrough Devices Program employ novel and/or complex technologies, the FDA may also consult with external advisors and experts in the appropriate fields of science and technology. In such cases, additional time might be required to assess the request. Moreover, the FDA would inform the applicant about the necessity to engage external experts and even consult regarding particular experts to be engaged. 
  2. Pre/Postmarket Balance of Data Collection. As it is stated in the guidance, the medical devices eligible for review under the Breakthrough Devices Program should still comply with any and all safety and performance requirements set forth by the general legislation on medical devices. The Agency also reserves the right to determine the particular scope of information to be collected depending on the specifics of the device in question and risks associated thereto. In particular, the FDA focuses on the information highlighting the clinical benefits of the medical device, as well as the risks arising when using it for the intended purpose, and the ways these risks could be managed. However, the regulating authority acknowledges that the uncertainty may take place at the moment of submitting the application. Hence, the FDA would grant the approval only in case the medical device subject to review complies with the applicable regulatory requirements. 
  3. Efficient and Flexible Clinical Study Design. The regulating authority intends to take steps to ensure that the design of clinical trials is as efficient and flexible as practicable, when scientifically appropriate”. In particular, the Agency would consider such aspects as the prespecified endpoints to be determined before the commencement of the study and describing the minimum clinically meaningful effect, as well as the intermediate, composite, and surrogate endpoints, and also the adaptive study designs. 
  4. Review Team Support. As it was already mentioned before, the Breakthrough Devices Program employee more efficient communications between the FDA and the interested party. As part of the review process, the submission would be transferred to the appropriate organizational unit of the FDA having the knowledge and experience necessary due to the complexity of the technology the medical device in question is based on. As it is mentioned in the guidance, the Breakthrough Device review teams are undertaking periodic training. 
  5. Senior Management Engagement. Due to the importance of medical devices subject to review, the representatives of the authority’s senior management are involved in the review process. 
  6. Priority Review. The concept of priority review is one of the most important principles of the Breakthrough Devices Program since it allows the Agency to allocate resources necessary to accelerate the review. 
  7. Manufacturing Considerations for PMA Submissions. The FDA also mentions that the medical device subject to review under the Breakthrough Devices Program should comply with the Quality System regulation, while the interested party shall provide the information sufficient to assess all related matters. 

Breakthrough Device Designation Request 

The present FDA guidance also describes in detail the processes and procedures associated with applying for an expedited review of the submission. First of all, the Agency outlines the main eligibility criteria the medical device in question should meet. In particular, the medical device should, inter alia:

  • Provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions; and
  • Represent breakthrough technologies; 
  • Do not have approved or cleared alternatives;
  • Offer significant advantages over existing approved or cleared alternatives, including the potential, compared to existing approved alternatives. 

The availability of the medical device subject to review should be in the best interest of patients.

Summarizing the information provided here above, the Breakthrough Devices Program implements a special framework intended to accelerate the review of vitally important medical devices and combination products. In particular, it provides special procedures to be followed by both the FDA and the interested party in order to improve the communications and make the whole process more effective. 

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