WebThe FDA’s Safer Technologies Program (STeP), modeled on the principles and features of FDA’s Breakthrough Devices Program, was launched in January 2024. FDA believes that STeP will help patients have more timely access to medical devices and device-led combination products by expediting their development, assessment, and review. WebJan 5, 2024 · The Safer Technologies Program for Medical Devices (STeP) is intended for devices and combination products that target conditions that are less serious than those …
Safer Technologies Program (SteP) - LinkedIn
WebDec 18, 2024 · Safer Technologies Program FDA first introduced the concept of the STeP program in its Medical Device Safety Action Plan released in April 2024. Under the program, FDA says it plans to apply features from the breakthrough devices program to devices that otherwise would not qualify that offer safety improvements over currently available devices. WebApr 20, 2024 · The April 20, 2024 online edition of Medtech Intelligence (MTI) features FDA Introduces the Safer Technologies Program for Medical Devices by Tara Lysechko, … mannen felicitatie
Understanding the Breakthrough Devices Program - AdvaMed
WebJan 7, 2024 · Credit: FDA. The Safer Technologies Program for Medical Devices (STeP) draft guidelines published by the US Food and Drug Administration (FDA) outline a voluntary programme for expediting the approval of promising treatments and diagnostics for non–life-threatening diseases. The guidance was open for public comment until 18 … WebJan 6, 2024 · Consistent with the Agency's statutory mission to protect and promote public health, FDA believes that this “Safer Technologies Program” or “STeP” will help patients … WebApr 20, 2024 · The Safer Technologies Program (STeP) is a new voluntary program modeled after the FDA’s Breakthrough Devices Program.It reduces the time to develop and obtain … mannen reclame