The new article highlights specific aspects related to the entrance review, the ones the authority will also assess when determining the eligibility of the product and application associated thereto for review under the appropriate framework.
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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 pathway that could be used to accelerate and streamline the process of placing on the market and making available for healthcare providers and patients the devices that are expected to offer a significant improvement in terms of safety in comparison to existing solutions. The said pathway could be applied to the products that are not intended to address severe life-threatening conditions and, consequently, are not eligible for the Breakthrough Designation Program, but are still vitally important and require special attention. The document provides clarifications regarding the existing regulatory framework, as well as recommendations to be followed by medical device manufacturers and other parties involved to ensure compliance with the respective regulatory requirements. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority additionally emphasizes that an alternative approach could be applied, provided such an approach is in line with the regulatory requirements set forth under the existing legislation and has been agreed with the authority in advance. For instance, the guidance describes in detail the eligibility factors to be considered by the FDA when determining whether the product in question is eligible for inclusion into STeP.
First of all, the authority describes the way the applicable regulatory pathway should be considered when determining the eligibility of the application. In this respect, the authority mentions that a device’s inclusion or denied inclusion in STeP does not constitute a formal decision regarding the applicable regulatory pathway or device classification; instead, the inclusion of a device in STeP indicates that, based on the information provided in the request and other information known at the time, the Agency expects that submission of a PMA (or PMA supplement), 510(k), or De Novo request will be necessary for marketing authorization. However, in terms of the review process described herein, the authority does not intend to provide clarifications regarding the particular framework to be applied, as this is the matter to be addressed separately and by the respective regulatory requirements and eligibility criteria.
The authority also mentions that some of the accessories to medical devices could meet the eligibility criteria for inclusion into STeP as well. The regulatory status of such products should also be determined separately under the applicable requirements and regulations. In this respect, the authority refers to a respective guidance document dedicated to medical device accessories and the determination of their regulatory status.
The STeP framework is initially intended to facilitate the process of development and subsequent application review of the products that are expected to significantly improve safety-related matters. Hence, a comparison of existing technologies and solutions is to be made to evaluate the expected improvement. The authority additionally emphasizes that since changes to medical devices intended to impact their safety usually require a new application to be submitted, the same approach should be applied concerning modified medical devices intended to be placed on the market under the STeP. The authority also acknowledges that sometimes the changes made to the device to improve its safety could be significant enough to make it impossible to find the proper predicate for the device initially placed on the market under the 510(k) framework. In such a case, it would be necessary to consider the submission of a PMA or De Novo request.
It is important to mention that the inclusion of a medical device into the STeP does not impact the obligations and responsibilities of its manufacturer as set forth under the respective framework. The scope of the STeP pathway applies to the initial review process conducted before the device is placed on the market, so the obligations related to the recalls and corrections remain intact.
The assessment to be performed under the STeP is limited to the evaluation of whether the device meets the eligibility criteria and, consequently, could be placed on the market under an accelerated procedure. The rest of the aspects to be assessed before the device is allowed for marketing and use in the US are falling outside the scope of the Safer Technologies Program, hence, should be assessed separately under the respective framework. As explained by the FDA, inclusion in the program should not be interpreted as a decision on the relative or absolute safety or effectiveness of that medical device, or any other medical products; rather, the program provides an opportunity for early and regular interaction with FDA as device development and review unfold. Since the device in question is expected to significantly improve the safety profile of an existing solution, the authority will take the steps to ensure that the application related to such device would be subject to review under the accelerated procedure to avoid delays due to the regulatory matters. However, the STeP pathway itself does not recognize the device as “safe”, it merely applies to the expedited review process, while all the applicable requirements, including the ones related to the safety, effectiveness, and labeling should be the same as set forth under the respective framework (a PMA, De Novo request, or 510(k)).
According to the guidance, an application for inclusion into STeP should be submitted to the authority before the submission of the main application for marketing approval. However, in certain cases, it could be admissible to submit the said application for inclusion together with or after the submission of the main application. At the same time, it is important to mention that in case of a “late” submission (occurred when the initial application is already being reviewed), the scope of STeP features and benefits available for the applicant would be limited in comparison with the full scope available in case of prior submission. Thus, the authority encourages medical device manufacturers to apply for STeP inclusion at the early development stages.
As it is further explained by the authority, it is allowed to include several devices into one submission, provided that all of them are intended to address the same safety issue. Hence, this would impact the review process of several medical devices at once.
In summary, the present FDA guidance outlines additional aspects to be considered when applying for inclusion in STeP. The document also highlights certain specific features of the program that are important in terms of understanding its scope and limitations.
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