‘STeP’ By ‘STeP’: FDA Finalizes Accelerated Pathway For Novel Devices, Combo Products
The US FDA released a final guidance document on 5 January that sets in place its new voluntary Safer Technologies Program, or STeP. Modeled after the agency’s burgeoning Breakthrough Devices Program, STeP is for innovative devices and device-led combo products heading for a PMA, 510(k) or de novo regulatory route that aim to treat less serious conditions than devices accepted into the Breakthrough program.
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FDA Takes 'STeP' Forward For Medtech Innovation With Safer Technologies Program Modeled On Agency's Breakthrough Pathway
People with non-life-threatening and reasonably reversible conditions will soon have access to innovative, early development-stage medical devices and device-led combination products thanks to the US FDA's upcoming Safer Technologies Program (STeP). STeP is modeled on, and is a complement to, the agency's popular Breakthrough Devices Program, an accelerated development pathway for devices that the agency finds could provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The US agency has announced another month of webinars aimed at labs and manufacturers that are (or have) developed diagnostic tests for the novel coronavirus.
ANSI/AAMI ST79:2017 has gained four new amendments, including recommendations and clarifications for “maintaining the integrity” of sterile process areas. The standard is used by health care professionals who use steam to sterilize devices and other medical products.