This month has been chock-full of new guidance documents released by FDA; draft guidances, updated documents, strategic plans, and more! A draft guidance that was released last Thursday, September 19th, caught our attention here at AcKnowledge RS, and we want to share with you what it’s all about.
The document released last week, “Safer Technologies Program for Medical Devices,” provides an in-depth look at a new program that will hopefully be implemented in the near future at FDA. The Safer Technologies Program, or STeP, has been designed to complement the Breakthrough Devices Program. According to the new draft guidance document, STeP is a voluntary program that will be introduced for medical devices and combination products that are expected to, “improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and moralities less serious than those eligible for the Breakthrough Devices program” (lines 104-107). FDA believes that the program will provide a public health benefit because the program aims to expedite the review process for medical devices that offer a significant safety advantage in treating or diagnosing diseases or conditions that are serious, but not so serious or debilitating as to make the device eligible for the Breakthrough Devices Program.
Inclusion in STeP requires a sponsor to submit a written request for inclusion via a Q-submission, and for FDA to then agree the device is a good fit for the program. The guidance document explains that as part of the Q-submission, sponsors will demonstrate their device’s eligibility by meeting and addressing the general and specific eligibility factors. To meet the general eligibility factor, the device should be subject to review under a premarket approval application (PMA), De Novo classification request, or premarket notification (510(k)). To meet the specific eligibility requirement, the device must not be eligible for the Breakthrough Devices Program, and significantly improve the benefit-risk profile of the device through substantial safety innovation. The safety innovation must provide one or more of the following:
(1) a reduction in the occurrence of a serious adverse event that is known,
(2) a reduction in the occurrence of a known device failure mode,
(3) a reduction in the occurrence of a known use-related hazard, or
(4) an improvement in the safety of another device or intervention.
Although the program is not yet active and no submissions are currently being accepted, comments on the draft guidance are welcomed until the close of the comment period (submit comments here until 11/18/2019). Only after FDA issues the final guidance will submissions be accepted for review. STeP has the potential to offer sponsors the opportunity to engage in a more expedited review process, even if their device does not qualify for the Breakthrough Devices Program, and the prospect of an opportunity to quickly bring substantial safety innovations to market is something we’re really excited about!
FDA’s Safer Technologies Program - STeP Guidance Document & Press Release
FDA’s Breakthrough Devices Program - Description