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. WebMar 14, 2024 · Mar 14, 2024. The Food and Drug Administration (FDA) has published a guidance document dedicated to the Safer Technologies Program. The document …

FDA Guidance on Safer Technologies Program: Principles

WebFeb 2, 2024 · The FDA is hosting a webinar on the Safer Technologies Program for industry and others interested in learning more about the program and the final guidance. Webinar … WebMay 7, 2024 · The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the Safer Technologies Program (STeP) – a special regulatory framework intended to facilitate the regulatory procedures associated with placing on the market the … brown county state park nature center hours

The FDA Breakthrough Devices Program (BDP) and Safer …

WebApr 13, 2024 · BOSTON--(BUSINESS WIRE)-- Pear Therapeutics (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced it has received Safer Technologies Program (STeP) for Medical Devices designation from the U.S. Food and Drug Administration (FDA) for … The Safer Technologies Program (STeP) is a voluntary program for 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 … See more The Safer Technologies Program is a collaborative program intended to help reduce the time it takes to develop and obtain marketing authorization for eligible … See more Devices subject to premarket approval applications (PMAs), premarket notification (510(k)) or requests for De Novo classification are eligible for inclusion in STeP if … See more To receive the most benefit from program participation, ideally a request seeking inclusion for a device in STeP will be sent prior to sending your marketing … See more WebKicking off the year on a high note, the U.S. Food & Drug Administration (FDA) released the highly anticipated Safer Technologies Program (STeP) Guidance Document earlier this month. The final guidance document comes just a little over a year after the draft was first released, which is especially impressive timing given the Center for Devices ... brown county state park indoor water park