The article provides an overview of the Safer Technologies Program, a special regulatory framework for medical devices introduced in the US.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, including medical devices, has published a set of guidelines and clarifications dedicated to the Safer Technologies Program (STeP), a voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities less serious than those eligible for the Breakthrough Devices Program. As it is further explained by the FDA, the scope of the said program covers the products that are intended to be used in the context of non-life-threatening diseases and conditions or the ones that could potentially be reversed. The program is intended to ensure the eligible devices are available for healthcare professionals and patients without undue delays based on regulatory matters while applying the same standards and requirements. It is also important to mention that the general pathways, such as premarket approval, 510(k) clearance, and De Novo marketing authorization remain applicable as prescribed by the respective regulations.
SteP: Key Benefits
According to the official notice, the STeP framework is intended to accelerate and streamline the review process for medical devices that meet eligibility criteria. The main purpose of the framework is to reduce the overall time needed to place a new product on the market and make it available for healthcare professionals and patients. The said goal is achieved by improving communications between the authority and the applicant entity to make them more efficient by focusing on the most important topics and matters during all the stages of the device development process.
As it was mentioned before, to determine the eligibility of a medical device subject to review for the STeP framework, special criteria should be applied. In this respect, the authority outlines the following eligibility factors:
- Not eligible for the Breakthrough Devices Program due to the less serious nature of the disease or condition treated, diagnosed, or prevented by the device;
- Should be reasonably expected to significantly improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations that provide for at least one of the following:
- A reduction in the occurrence of a known serious adverse event;
- A reduction in the occurrence of a known device failure mode;
- A reduction in the occurrence of a known use-related hazard or use error;
- An improvement in the safety of another device or intervention.
The FDA further describes the procedure to be followed when applying for participation in STeP – for this purpose, an interested party should send a request for inclusion before applying itself (under one of the existing pathways). In particular, an interested party should submit a Q-Submission with the appropriate request indicated therein (in the cover letter). The general procedure to be followed is described in the guidance document dedicated to the said framework, published earlier by the FDA. Furthermore, it is also stated that the authority may identify devices that could be good candidates for the Safer Technologies Program and recommend that sponsors of such devices consider applying to the program. A request to be submitted by an interested party should address, inter alia, the following aspects:
- General information about the medical device or device-led combination product is subject to review;
- Indications for use;
- The way the product is expected to improve the overall safety;
- Regulatory history;
- Confirmation of compliance with the eligibility criteria and objectives of the program;
- Indication of the particular submission an interested party intends to file, and the framework to be used (e.g., PMA, or De Novo request).
Once the appropriate request has been submitted, the authority will review the information provided and request additional details, should they be reasonably needed to complete the review within 30 days from the date the initial request has been received by the FDA. At the same time, the overall timeline for deciding on the acceptance or refusal is longer – the authority will make its final decision and communicate it to the applicant within 60 calendar days from the date the request has been received by the authority.
The authority additionally emphasizes the importance of efficient communications during the whole process – in particular, the authority expects the applicant to provide the additional information requested promptly. Should an applicant fail to provide the information requested by the FDA within the aforementioned timeline, the authority may decide to deny the request for joining the STeP.
Once the decision to include the device in the STeP has been taken, an applicant will be able to request feedback from the authority regarding the device in question in a more efficient way – for instance, in the course of sprint discussions and requests for discussions on a Data Development Plan. The authority also intends to allocate additional resources to handle the requests related to Q-Submissions and Investigational Device Exemption (IDE) applications.
In summary, the new framework introduced by the FDA is intended to improve the regulatory procedures and reduce the time necessary to make available on the market the products that are expected to offer safer solutions for healthcare professionals and patients. The new regulatory approach is based on principles similar to the Breakthrough Devices Program, but due to the lower eligibility threshold could be used for a wider range of medical devices. According to the official notice, FDA intends for STeP to incorporate similar features offered under the Breakthrough Devices Program, such as interactive and timely communications, early engagement on Data Development Plans (DDPs), sprint discussions, and senior management engagement. The new approach also provides the use of voluntary consensus standards recognized by the FDA for demonstrating conformity with the applicable safety- and performance-related requirements.
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