FDA Marches Forward With 'STeP' Program To Aid Development Of Significantly Safer Medtech Products
The US agency is planning to launch another accelerated device approval program along the lines of its successful Breakthrough Devices Program. But this one, the Safer Technology Program (STeP), would focus on devices with enhanced safety features.
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Device And Drug Accelerated Approval Pathways Important To Cancer Patients, US FDA Oncology Chief Pazdur Says
The Food and Drug Administration’s increased use of hastened approval pathways for innovative medical products, including new genomic device/drug combinations, has come in for criticism from some US Senators recently. But the patient group Friends of Cancer Research (FOCR) endorsed the approach at a 10 December meeting on Capitol Hill featuring FDA’s Oncology Center of Excellence director Richard Pazdur.
US FDA issued a final guidance that sets out requirements for its new Breakthrough Devices Program mandated by Congress. Under the new program, which replaces the Expedited Access Pathway, sponsors have more certainty about how quickly they will get responses from the agency and fewer requirements when setting up early interactions.
US FDA Nov. 20 announced plans for a broad series of updates to its Medical Device Safety Action Plan for the next several months, with the goal that FDA "is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.