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With Release Of New Guidance Document, FDA Launches Safer Technologies Program for Medical Devices
By Mark Durivage, Quality Systems Compliance LLC
The FDA’s Center for Devices and Radiological Health (CDRH) releasedthe
Safer Technologies Program for Medical Devices (STeP)
Guidance for Industry and Food and Drug Administration Staff on January 6, 2021, with plans to begin accepting applications for STeP beginning March 8, 2021. The two-month delay is due to the expected time to “operationalize” the program, which is a voluntary program applicable to “certain medical devices and device-led combination products 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.” ....

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