FDA Issues Final Guidance on the Safer Technologies Program (STeP) for Medical Devices | Manatt, Phelps & Phillips, LLP
To embed, copy and paste the code into your website or blog: On January 6 of this year, the Food and Drug Administration (FDA) released a final guidance on the Safer Technologies Program (STeP) for Medical Devices. The concept of STeP was first introduced by FDA in 2018 with the goal of expediting development and FDA review of medical devices or device-led combination products that are likely to offer safer treatment or diagnosis of certain diseases and conditions as compared to currently avail...
Phelps Phillips Breakthrough Devices Program Data Development Plan Drug Administration Safer Technologies Program Ste Safer Technologies Program
Source: jdsupra.com