How, When, and Why to Leverage the FDA’s Safer Technologies Program (STeP)

May 12, 2023 | White Paper |

Are you in early stage development of a device or device-led combination product? The FDA has rolled out a number of initiatives over the past several years to facilitate more timely access for patients to innovative medical devices and technologies.

One such initiative, the Safer Technologies Program (STeP), is intended for certain devices that are expected to provide a significant improvement in safety to what’s currently available in the market. STeP supports sponsors with more opportunities for collaboration, review and feedback during the development process, providing a potentially faster pathway to marketing authorization.

Interested in learning more? Click to read our latest MEDIcept White Paper.

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