The Food and Drug Administration (FDA) has published a guidance document dedicated to the Safer Technologies Program. The document constitutes a final version of the guidance issued previously in September 2019. Due to its legal nature, the guidance does not introduce any mandatory rules and requirements the parties involved shall follow but provides certain clarifications and recommendations to be considered instead. The Agency also mentions that an alternative approach could be applied, providing that it complies with the applicable requirements and has been agreed with the regulating authority in advance.
Safer Technologies Program: the Purpose
The present FDA guidance is dedicated to the new regulatory framework intended to improve the safety of medical devices and combination products used in the context of non-life-threatening diseases. For this purpose, the Agency introduces a new voluntary program and announces that medical device manufacturers may participate therein. The scope of a new program covers the medical devices intended to be placed on the market under a premarket approval application (PMA), De Novo classification request, or premarket notification (510(k)) frameworks. According to the document, the Safer Technologies Program (the STeP) would expand and ensure the availability of medical devices for the patients by facilitating the development, design, and evaluation of medical devices. In general, the STeP is based on the same principles as the FDA`s Breakthrough Devices Program intended to expedite placing on the market of the medical devices intended to address complex conditions and life-threatening illnesses. For instance, when developing the STeP, the Agency has implemented such elements as interactive and timely communications, early engagement on Data Development Plans (DDPs), sprint discussions, as well as engagement of senior management.
The present FDA guidance also contains references to the FDA-recognised voluntary consensus standards the medical device manufacturers may refer to in order to demonstrate conformity with the applicable safety and performance requirements.
It is also important to mention that the actual implementation of the program described herein would take up to 60 days from the date the present FDA guidance has been initially published. Consequently, the Agency would not accept applications for participation in STeP within this period of time, unless the new program would be fully operational.
Regulatory Background
The FDA, as the US regulating authority in the sphere of medical devices, performs continuous development and implementation of special regulatory frameworks intended to expand the availability of novel medical devices meanwhile ensuring their compliance with the applicable safety, performance, and effectiveness requirements set forth under the current legislation, including the Federal Food, Drug, and Cosmetic (FD&C) Act. As it was already mentioned before, the FDA has already developed and implemented the Breakthrough Devices Program, which replaced the Expedited Access Pathway and Priority Review Program existing before. However, the scope of this program covers only certain medical devices that meet the appropriate eligibility criteria – in particular, it could be applied in the case of medical devices intended to diagnose or treat severe diseases and life-threatening conditions. From a regulatory standpoint, additional measures are necessary to make such devices available for the patients within the shortest period of time and to reduce to the lowest extent possible the regulatory burden carried by the medical device manufacturers focused on such products. However, the FDA also acknowledges the importance of ensuring the safety of any and all medical devices allowed to be marketed in the US. Thus, the Agency intends to establish a balance between safety and innovations.
Despite the general success of the Breakthrough Devices Program, the regulating authority also finds out that certain medical devices that do not meet the eligibility criteria could still be important for the patients. Hence, it was necessary to develop a separate program with a different scope of medical devices covered while using the same principles and approaches that have already confirmed their effectiveness. With this in mind, the new Safer Technologies Program has been developed.
Key Principles of STeP
According to FDA guidance, the new program employs the same approach as the aforementioned Breakthrough Devices Program. In particular, it is also comprised of two phases:
- A formal request for inclusion in STeP through a Q-submission, and
- Actions aimed at acceleration of the development of the medical device in question and its examination by the regulating authority (including the review of pre-submissions and marketing submissions).
As it was already mentioned before, the new program applies principles and approaches initially employed by the Breakthrough Devices Program. It prescribes that the applicant (medical device manufacturer) and the FDA shall actively cooperate to accelerate the regulatory procedures. In particular, the applicant shall resolve all scientific and regulatory issues within the shortest possible period of time, while the Agency from its side would facilitate the review of the submissions.
The FDA also mentions that in terms of the distribution of internal resources, the Breakthrough Device Program would have higher priority over the new Safer Technologies Program.
The main principles the new program is based on include, inter alia, the following ones:
- Interactive and Timely Communication. As was already mentioned before, efficient communications are one of the key elements of the new program. According to the guidance, the FDA and the applicant shall: agree on the goals of the interaction and feasibility of response timeframes prior to submission, utilize redlined versions of documents being reviewed and/or revised interactively for transparent communication concerning proposed changes, and utilize summary tables, documents, and/or FDA correspondence to communicate points of agreement, disagreement, or unresolved issues at the conclusion of a review period. Since the medical devices subject to review under the STeP framework could be based on novel technologies, the Agency reserves the right to engage external specialists and arrange additional consultations reasonably necessary to assess the case.
- Review Team Support. In the context of the program, the Agency intends to provide intensive review team support and increased involvement of the senior management. In particular, senior management would be involved in the interactions regarding the regulatory submissions in order to facilitate and accelerate the review process.
- Review of Regulatory Submissions. The FDA states that it is going to provide additional review resources for the review of regulatory submissions for medical devices under the STeP framework in order to reduce the time necessary to place on the market the medical devices based on novel or complex technologies. At the same time, the Agency also mentions that the overall time necessary to review the submissions under the Safer Technologies Program may exceed the usual time for review due to the additional scientific and regulatory issues associated with the innovative products the new program is to be applied for.
Summarizing the information provided here above, the FDA has developed and commenced the implementation of an entirely new program for innovative medical devices in order to expand their availability and reduce the regulatory burden. The STeP framework is based on the same principles as the existing programs but expands the scope of eligible medical devices. The Agency expects the new program would make the medical devices based on complex technologies more accessible for the patients.
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