Earlier this year, the United States Food and Drug Administration (FDA) finalized guidance for devices and combination products, Safer Technologies Program (STeP) for Medical Devices. The new guidance aims to improve the path for manufacturers of devices and combination products that target conditions that are less serious than those that fall under the Breakthrough Devices Program.
The new, voluntary program is 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 and mortalities less serious than those eligible for the Breakthrough Devices Program. Examples of devices that may fall into this category include those that treat or diagnose non-life-threatening or reasonably reversible conditions. Devices and device-led combination products are eligible for this program if they are subject to review under a premarket approval application (PMA), De Novo classification request (“De Novo request”), or premarket notification (510(k)), with additional specific eligibility factors outlined in the guidance.
In addition to addressing less-serious diseases and conditions, devices that qualify for STeP should “significantly improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations.”
FDA used the principles and features of its Breakthrough Devices Program as a model for this program and intends for the program 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.
FDA expects to need up to 60 days to perform activities to operationalize STeP following issuance of the final guidance. FDA does not intend to accept requests for inclusion in STeP within this time, and therefore, it is likely this path will not be open until early March 2021.
Draft Guidance and Comments
The final guidance follows the September 2019 issuance of draft guidance on the same topic. After the draft guidance was issued, public comments were received and reviewed, which led to the FDA actually providing additional examples of devices that would qualify under the program, clarifying the scope of the program, and clarifying the review timeline. The final guidance also makes it apparent that all statutory requirements for medical device marketing authorizations are still applicable and the FDA will continue to use “least burdensome’ policies. In addition, the appendix to the guidance includes an example of what a Q-submission request for STeP inclusion should look like.
According to the Federal Register notice of the final guidance publication, “FDA believes that this “Safer Technologies Program” or “STeP” will help patients have more timely access to these medical devices and device-led combination products by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, De Novo marketing authorization, and 510(k) clearance.”