The new article describes in detail the core principles of the Safer Technologies Program introduced by the FDA to improve the regulatory framework for certain types of medical devices.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the FDA Safer Technologies Program (STeP), a special regulatory pathway for medical devices offering safer approaches to diagnosis and treatment. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach complies with the respective regulatory requirements and has been agreed with the authority in advance.
Program Principles: Key Points
As it was mentioned before, STeP is based on the same two-phase approach as used for the Breakthrough Devices Program and includes the following stages:
- In the first phase, intersected sponsors formally request inclusion in STeP through a Q-submission.
- The second phase encompasses actions to expedite the development of the device and review subsequent regulatory submissions (e.g., pre-submission, marketing submissions).
The document further describes the main principles which establish the basics of the program, as well as the approach to be followed by the authority when reviewing the applications submitted by the interested parties. In particular, it is stated that STeP employed many principles initially developed for the Breakthrough Designation Framework, as they allow to significantly improve the review process. The authority additionally emphasizes the importance of establishing an efficient collaboration between the applicant entity and the FDA to ensure that all the issues arising are addressed in time, and all the important aspects are duly covered, while the least burdensome approach is followed. The authority mentions that all the information requested by the FDA from the sponsor should be provided within the respective timelines to streamline the process and avoid undue delays – since the pathway is intended to be applied concerning medical devices offering safer solutions, time is of the essence, and it is important to reduce the time needed to complete the regulatory procedures and make such devices available to healthcare professionals and patients to the maximum extent possible. At the same time, the authority itself will consider the way its review resources are used to ensure the highest efficiency of their allocation. At the same time, the authority mentions that in case of doubts, the review under the Breakthrough Devices Program would have a priority.
According to the guidance, the STeP principles include, inter alia, the following ones
Interactive and Timely Communication
As it was mentioned before, the effectiveness of communication between the sponsor and FDA is vitally important. Thus, the parties involved should take all the steps to ensure the said effectiveness including, inter alia, the following ones:
- Agree on the goals of the interaction and feasibility of response timeframes before submission of, or early in the review of, one of the relevant regulatory submissions listed above;
- 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 (e.g., written feedback, meeting minutes) to communicate points of agreement, disagreement, or unresolved issues after a review period.
The authority also mentions that due to the specific nature of medical devices subject to review under the pathway (some of them may be based on novel technologies), the involvement of external specialists could be required to ensure the completeness of review and reliability of its results.
Review Team Support
Due to the importance of the matters, the authority intends to ensure the involvement of its senior management in the review process. For instance, senior management intends to be involved in regulatory submissions for devices in STeP to ensure adherence to programmatic principles and to support efficient and timely dispute resolution when points of disagreement cannot be resolved quickly. The authority further mentions that the teams participating in the review under the STeP framework would undertake special training to be able to apply the most efficient review methods and deal with innovative technologies that could be used in medical devices subject to review.
Review of Regulatory Submissions
To facilitate the process, the FDA intends to prioritize review under the STeP framework over review under other pathways to reduce the time needed to make the devices covered by its scope available to patients. At the same time, due to the specific nature of medical devices subject to review and the wide use of innovative technologies, the overall review process could take longer than for other medical devices, even though the highest priority will be granted, just due to the need for the involvement of additional specialists with relevant qualifications and knowledge. Thus, to avoid delays, the applicant entity should take all the actions to ensure that the information requested by the FDA is provided without undue delay.
Benefit-Risk Assessments and Pre/Post-Market Balance of Data Collection
The authority additionally emphasizes that even when the STeP pathway is followed, the device in question should still comply with any requirements set forth under the basic framework (e.g., PMA or De Novo request) in terms of safety and effectiveness. Hence, when making the appropriate decision, the authority will consider the respective factors in the course of the benefit-risk determination. In particular, the authority will consider the evidence submitted by an interested party when evaluating the benefits and risks associated with the device in question. The FDA further provides references to the respective guidance documents to be followed in this respect. The scope of evidence and supporting data to be submitted should be determined depending on the submission type and regulatory requirements set forth by the respective regulations based on the device in question, its characteristics, and features. In particular, the authority refers to the guidance document dedicated to the determination of the substantial equivalence and benefit-risk approach associated thereto.
The other principles covered by the scope of the guidance include the following ones:
- Efficient and flexible clinical study design – for devices in STeP, FDA intends to consider proposals for efficient and flexible clinical study designs, including those incorporating real-world data sources, that may be used to support the proposed indication and/or labeling; and
- Manufacturing considerations for PMA submissions state that the product in question should meet the applicable requirements set forth under the Quality System regulation, while the review of the respective factors will be accelerated.
In summary, the present FDA guidance outlines the main principles of the safer technologies program and highlights the key points associated thereto. The said principles are intended to ensure efficient cooperation between the parties and reduce the regulatory burden to ensure the availability of medical devices based on innovative technologies and offer safer solutions for patients and users.
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