Devices that do not meet the criteria for the Breakthrough Devices Program may have a new option under the Safer Technologies Program for Medical Devices (STeP). Read our previous post on the the Breakthrough Devices Program here: FDA Breakthrough Devices Program Draft Guidance. SteP is a voluntary program for certain medical devices 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.” STeP-eligible devices could be those that treat or diagnose non-life-threatening or reasonably reversible conditions. STeP will mimic features of the Breakthrough Devices Program like interactive and timely communications with the FDA, early engagement on Data Development Plans, sprint discussions, and senior management engagement.
The FDA has released a final guidance document on STeP linked here: Safer Technologies Program for Medical Devices. As discussed in the guidance document and on the STeP webinar hosted by the FDA on February 1, 2021, there are two phases to STeP: 1) a request for program inclusion, and 2) program feedback for accepted sponsors. There are two factors for STeP inclusion:
- General Eligibility Factor: the device must be subject to marketing via a PMA, De Novo request, or 510(k) submission.
- Specific Eligibility Factors:
- The device is not eligible for the Breakthrough Devices Program, and
- The device is 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 d. an improvement in the safety of another device or intervention.
The FDA has created STeP in an effort to provide timely access to safer medical devices for less serious conditions that still benefit from devices aiming to improve health outcomes. The latest communication from the FDA is that sponsors may submit STeP inclusion requests via a Q-Sub beginning March 8, 2021. However, the change in administration could cause delays in program commencement. Follow updates on STeP at the FDA webpage linked here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medical-devices?utm_medium=email&utm_source=govdelivery.