FDA formally announced the Safer Technologies Program (STeP) in a December 2018 press release from then-FDA Commissioner Scott Gottlieb, M.D., and Director of CDRH Jeff Shuren, M.D. Details on the program were limited other than to say that the program would be designed to complement the Breakthrough Devices Program and would apply principles of the Breakthrough program “to devices with the potential for significant safety improvements as compared to available treatment or diagnostic options” that wouldn’t otherwise qualify as Breakthrough.
On September 19, CDRH issued a draft guidance, Safer Technologies Program for Medical Devices, providing details around the program. As promised in the press release last year, the guidance states that the STeP program will offer, “as resources permit,” features similar to those in the Breakthrough Devices Program, including interactive and timely communications, early engagement on Data Development Plans, prioritized review, and senior management engagement.
Once finalized, which FDA estimates it will take at least 60 days after issuance of a final guidance, the program will be available to devices that have the potential to significantly improve safety. To be accepted into the program, a manufacturer will need to demonstrate to FDA’s satisfaction that it meets the following criteria:
- are 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.
As to the first criteria, the draft guidance notes that this could be a disease or condition that is either non-life-threatening or reasonably reversible. With regard to the second criteria, FDA intends to consider devices for inclusion in STeP that have the potential for significant safety improvements over the current standard of care, including devices, drugs, and biologics. The draft guidance notes that any new safety features must not compromise effectiveness. Because at the time of application, a sponsor may not yet know how safe or effective a new device will be, the draft guidance states that FDA will evaluate if “there is a reasonable expectation for technical and clinical success of the device based on information submitted.” While not expressly clear in the draft guidance, we expect the type of information that can demonstrate a reasonable expectation of success will include, like the Breakthrough Devices program, bench testing, pre-clinical testing, or literature, among other things.
Procedurally, the draft guidance states that applications for inclusion in the STeP program should be submitted as a pre-submission. FDA anticipates that it will have a substantive interaction with an applicant within 30 days of receipt, and the Agency will make a final decision within 60 days of receipt. While the program may offer promise, it’s unclear if sponsors will actually see a measurable benefit. FDA resources are often limited, and the program will only offer increased interaction when resources are available. Nonetheless, we are optimistic that devices that increase safety will garner increased attention during development and review.