The new article addresses the aspects related to the factors for Safer Technologies Program (STeP) entrance and review process.
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 Safer Technologies Program (STeP) – a special regulatory framework intended to facilitate the regulatory procedures associated with placing on the market the products that are offering safer solutions to healthcare professionals and patients. The document provides an overview of the applicable regulatory requirements, as well as recommendations to be followed to ensure compliance thereto. Clarifications provided in the document should be considered by medical device manufacturers and other parties involved in operations with medical devices. It is important to mention that due to the non-binding nature of the guidance, provisions thereof are not 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 legislation and has been agreed with the authority in advance.
Under the general rule, inclusion in the said program could take place only upon request of the party responsible for the device in question, provided such request has been reviewed and approved by the authority. According to the guidance, to request entrance into STeP, interested sponsors should first evaluate whether they believe their device, which could be a modification to an existing device, meets the general eligibility factor and the specific program factors. The FDA further describes all the aforementioned factors in detail.
General Eligibility Factor
To be eligible for inclusion in the Program, the product subject to review should be eligible for one of the main pathways: PMA, De Novo request, or 510(k). It is also stated that device-led combination products are also eligible for inclusion into STeP. At the same time, while reviewing the particular request, the authority will assess whether the safety improvement is associated with the device part of the product.
The authority additionally emphasizes that for the product to be eligible for inclusion into STeP, both general and specific eligibility factors should be met.
Specific Eligibility Factors
The authority also outlines specific eligibility factors the product should meet to be eligible for inclusion into STeP. According to the guidance, the product in question:
- Should not be eligible for the Breakthrough Devices Program due to the less serious nature of the disease or condition treated, diagnosed, or prevented by the device; and
- Should be reasonably expected to significantly improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations that provide for one or more 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, or
- an improvement in the safety of another device or intervention.
Considerations for Evaluating Specific STeP Eligibility Factors
The authority further describes additional aspects to be taken into consideration when evaluating the specific STeP eligibility factors listed hereinabove.
The first specific factor is related to the disease the product is intended to address, and its severity. Under the general rule, to fall within the scope of the Breakthrough Devices Program, the product should be intended to be used in the context of life-threatening conditions. At the same time, the authority acknowledges that timely access to medical devices could be vitally important even if the diseases and conditions they are intended to address are less severe, and this is the purpose for which the safer technologies program has been introduced. Hence, the products falling within the scope of the Program could be intended to address non-life-threatening conditions, but they would still be eligible for the accelerated procedure, provided they are expected to offer safer solutions. Thus, as explained by the FDA, the device doesn’t need to be intended to diagnose or treat serious diseases and conditions with severe consequences to be eligible for inclusion in STeP, as the approach to be applied when determining the eligibility is based not on the disease or its consequences, but on the technologies used and the way they impact the safety of the device when used for its intended purpose.
The second eligibility factor is related to the way the device in question is expected to improve the benefit-risk profile of existing treatment options in comparison to the products which are currently available and are used in the respective cases. As it is stated by the FDA, this second eligibility factor encompasses several elements including the significance of the anticipated improvement to the benefit-risk profile, the type of safety innovation proposed, and whether the device addresses one of four specific categories of safety improvement. The document further describes how each of these elements will be assessed by the FDA when reviewing the application submitted by a party interested in the inclusion of its product into STeP.
In particular, the authority will evaluate whether the product in question can improve significantly the benefit-risk profile of existing treatment options, especially in situations when the use of similar products available is associated with significant risks or the probability of adverse events’ occurrence is relatively high. According to the guidance, FDA intends to evaluate the significance of the safety benefit within the context of the overall benefit-risk framework for the particular device and proposed intended use, taking into account the intended patient population, the severity of the identified safety issue, the severity of the targeted disease or condition, as well as other available treatment or diagnostic alternatives. Consequently, the use of the product intended to be included in STeP should result in a certain improvement to the existing diagnosing or treatment options, and such an improvement should be clinically meaningful. At the same time, the authority additionally emphasizes that the safety-related improvement should not affect adversely the effectiveness of the device.
Thus, to be eligible for review under the STeP, a medical device should provide an improvement to existing solutions in comparison to medical devices that are currently available on the US market.
In summary, the guidance highlights the key points to be considered when assessing the eligibility of a medical device for inclusion in STeP. The document outlines the main eligibility criteria and describes in detail the way they would be assessed by the authority when determining the eligibility of the product in question.
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