The Food and Drug Administration (FDA) has published a guidance document dedicated to the Breakthrough Devices Program, a special framework intended to facilitate the review of important submissions and accelerate the process of placing vitally important medical devices on the market to ensure and expand their availability. The document is intended to provide medical device manufacturers and other industry representatives with additional clarifications and recommendations to be considered before applying for participation in the Breakthrough Devices Program.

Designation Request 

In order to participate in the Breakthrough Devices Program, the interested entity shall submit the appropriate request. The first step of the process includes the consideration of compliance with the eligibility criteria the medical device in question shall meet. In particular, at this step, it is important to demonstrate that the medical device provides more effective treatment or diagnosis in comparison to ones already registered and placed on the market. Since such a decision would be made by the regulating authority before marketing authorization, it would be based on reasonable expectations regarding the performance of the device. The FDA additionally emphasizes that a complete set of clinical data is not required. For instance, the interested party may provide a literature review or preliminary data of any kind, including bench, animal, or clinical. 

As it was already mentioned before, the medical device subject to review under the Breakthrough Devices Program should be intended to address life-threatening diseases or conditions. 

Other criteria to be applied by the FDA are based on the device-specific aspects. In this regard, the following criteria should be applied:

  • A medical device should be based on a breakthrough technology (i.e. some novel technologies, or novel application of existing ones);
  • There should be no already approved or cleared alternative for the device in question, that could be used for the same purpose with the same level of safety and effectiveness;
  • A medical device subject to review should provide significant advantages in comparison to already approved or cleared medical devices;
  • The availability of a medical device in question should be in the best interest of patients. When applying this criterion, the FDA would evaluate the impact of the device in general. The device would meet this criterion in case it helps to avoid serious harm or reduces the potential for harmful factors associated with the therapies that are already available. The Agency also states that this criterion could be applied in case of medical devices intended to address failures related to a critical component of an existing medical device. According to the guidance, a medical device developed in collaboration with a Federal agency is deemed to meet this criterion by default. 

The present FDA guidance also provides additional considerations with regard to the special framework described therein. Under the general rule, a sponsor as a party interested in placing a medical device on the market may apply for participation in the Breakthrough Devices Program any time prior to the submission of an application under section 515(c), a notification under section 510(k), or a petition for classification under section 513(f)(2). For this purpose, a sponsor should also indicate the particular type of application (e.g. premarket notification, or De Novo request – a special framework to be applied in case of entirely new medical devices for which there is no equivalent product already placed on the market). The regulating authority additionally emphasizes that a request for Breakthrough Device designation submitted within a marketing submission or after it has been duly received would not be considered. 

As it is stated in the FDA guidance on the Breakthrough Devices Program, the appropriate designation could be granted for several devices having the same intended purpose. Hence, several requests for designation could be subject to review simultaneously. At the same time, in case if at least one of these medical devices would be placed on the market by the virtue of the ordinary or De Novo frameworks, all other devices subject to review would not be eligible for destination unless the sponsors would demonstrate that the device still meets any and all applicable criteria. 

The document also provides specific rules to be applied in case of combination products consisting of a medical device itself and medicine intended to be used together with the device. At the same time, the Agency mentions that there could be specific regulatory issues associated with such devices. 

General Provisions 

The new classification rules for medical devices adopted in Kazakhstan describe in detail the approach to be applied for the classification of medical devices in accordance with the potential risks associated with their use for the intended purpose. These rules should be applied for any and all medical devices manufactured or imported in the Republic of Kazakhstan. 

The new classification rules provide the definitions of the most important terms used in the context of the risk-based classification of medical devices including, inter alia, the following ones:

  • Active diagnostic medical devices – active medical devices, intended for the provision of the information for the purpose of diagnosing, monitoring of treatment or changes to the physiological conditions, illness, or congenital defects;
  • Active therapeutic medical devices – active medical devices intended for protection, alteration, replacement, or restoration of biological functions or structures, associated with the treatment or wound care;
  • Active medical devices – medical devices used separately or in connection with other medical devices, which require the use of energy other than that produced by the human or gravity. It is important to mention that independent software (software as a medical device) should be classified as an active medical device; 
  • Potential application risk – a combination of the probability of causing harm when using medical devices in accordance with the intended purpose indicated by the manufacturer, and also the severity of such harm;
  • Safety of a medical device – the absence of the unacceptable risk when using a medical device, associated with causing harm to the life or health of a human, as well as the environment;
  • The intended purpose of a medical device – a documented resolution of a medical device manufacturer regarding the intended use of a medical device, based on its features, reflected in its technical characteristics, instructions for use, or user guide. 

Besides the aforementioned terms, the new rules also provide the definitions of such terms as “medical devices for temporary use,” “medical devices for long-term use,” “surgical invasive medical devices,” and “in vitro diagnostic medical devices.”

Breakthrough Designation Review Process and Withdrawal 

The present FDA guidance describes in detail the designation review process to take place upon submission of a “Designation Request for Breakthrough Device”. In this regard, it is important to mention that the Agency is also entitled to initiate participation in the Breakthrough Devices Program itself by recommending the sponsor to apply for this option. Under the general rule, it would take up to 60 calendar days from the date of the initial request for the FDA to assess the submission and make a final decision on the matter. Within the first 30 days of this period, the FDA may also contact the sponsor and ask for additional information and clarifications. If the sponsor would fail to provide the requested information in time, the Agency is entitled to deny the initial request. 

According to the guidance, a sponsor also has a right to request the withdrawal. At the same time, the FDA is entitled to withdraw designation for one of the following reasons: 

  • A medical device is no longer eligible for a Breakthrough Device designation since it no longer meets the applicable eligibility criteria;
  • The information submitted by the sponsor when applying for participation in the Breakthrough Devices Program contains false statements. 

Features of the Breakthrough Devices Program 

The Agency acknowledges that due to the fact that the special regulatory framework described herein has been initially introduced not far from now, certain regulatory issues may arise when applying it, especially with regard to the evaluation of safety and effectiveness of the medical device. Thus, in order to improve and facilitate the whole process, the FDA encourages the sponsors to actively cooperate during all stages. In particular, an interested party may ask for feedback from the FDA at any time before the marketing application has been submitted. The Agency also suggests applying “sprint” discussions format which provides that parties shall reach an agreement on a particular matter within a pre-defined period of time, while all interactions taking place during this period should be agreed upon by both parties and would actually depend on a medical device subject to review and its specific features. The FDA states that it is important to focus on a single topic with specific goals. As part of this process, the parties would define the interaction schedule and agree on documentation and supporting materials to be provided.

Summarizing the information provided here above, the present FDA guidance outlines the key aspects related to the Breakthrough Devices Program – a special regulatory framework to be applied in case of vitally important medical devices. In particular, the guidance highlights eligibility criteria, and also describes in detail the processes and procedures taking place in the course of submission of the designation request and its review. 

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