USA – FDA updates off-the-shelf software guidance to reflect least burdensome approach
The US Food and Drug Administration (FDA) has reissued a final guidance on off-the-shelf (OTS) software used by medical devices, which aims to reduce...
USA – FDA details proposed 510(k) modernization with trio of draft guidances
The US Food and Drug Administration (FDA) has announced new steps it is taking to modernize the 510(k) program, which include updates on its...
USA – FDA issues final guidance on obtaining informed consent in drug and device...
The US Food and Drug Administration (FDA) on Tuesday announced it has finalized guidance to help institutional review boards (IRBs), clinical investigators, and sponsors...
USA – Opioid use disorder: FDA drafts guidance on clinical considerations for devices
Sponsors of clinical trials of medical devices to treat opioid use disorder (OUD) face “complex challenges,” the US Food and Drug Administration (FDA) said....
USA – FDA recognizes new medical device sterilization standards
Amid a regulatory effort by the US Environmental Protection Agency (EPA) to limit the use of ethylene oxide (EtO), the Food and Drug Administration...
USA – FDA warns device makers for GMP issues, unauthorized uses
The US Food and Drug Administration (FDA) recently warned a hemodialysis manufacturer for marketing their products without submitting a premarket notification for one of...
USA – Medtech groups warn EPA of ‘devastating’ impact of proposed EtO rules
Two proposed regulations to limit the use of ethylene oxide (EtO) and the facilities that use the sterilizing agent could have a “devastating” impact...
USA – FDA drafts guidance to aid orthopedic implant guide makers
The US Food and Drug Administration (FDA) has issued draft guidance that outlines its expectations from sponsors filing premarket submissions for patient-matched guides used...
USA – Content of Premarket Submissions for Device Software Functions
This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of...
USA – FDA revamps device software premarket submissions guidance
The US Food and Drug Administration (FDA) this week finalized guidance on the content of premarket submission for software functions in medical devices. The...
