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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 devic...