Jan 12, 2021

The US Food and Drug Administration (FDA) has published a final guidance document introducing the “Safer Technologies Program,” abbreviated as “STep." STeP is a voluntary program designed for specific medical devices that are expected to significantly improve the safety of currently available treatments or diagnostics for diseases and conditions considered less serious than those eligible for the Breakthrough Devices Program, after which STeP is modeled. Devices may be eligible for this program if they are subject to review under a premarket approval (PMA) application, De Novo request, or 510(k) premarket notification. A draft of this document was initially released in September 2019.

The guidance explains the guiding principles of STeP and provides a breakdown of the program’s acceptance and review policies. It also discusses the mechanisms that the FDA makes available for feedback on device development, including sprint discussion and data development plan (DDP) review. Appendix 1 outlines the recommended information that should be included in a Q-submission requesting inclusion in STeP. Accordingly, the agency’s guidance on the Q-Submission Program has been updated to include submissions related to STeP in the list of interactions being tracked in the Q-Sub program.

Webinar and Q&A page provide further information about STeP

The FDA will be hosting a webinar on February 1, 2021 to summarize details about STeP and go over the contents of this guidance. Approval of requests for inclusion in STeP is to begin on March 8, 2021.

Further information and resources related to STeP can be found on the FDA Q&A page, Safer Technologies Program (STeP) for Medical Devices.

Learn more about US FDA medical device regulations at Emergo by UL:

  • US FDA 510(k) consulting for medical device and IVD companies
  • FDA submission support for medical devices and IVDs
  • Whitepaper: Medical device testing requirements for FDA 510(k) submissions
  • Whitepaper: Early communication with the US FDA

Author

  • Timothy Herr

Related