USA – Best Practices for Selecting a Predicate Device to Support a Premarket Notification...
FDA developed this document to provide guidance to industry and FDA staff about best practices in selecting a predicate device for premarket notification ...
USA – FDA finalizes guidance on use of human factors studies in combination product...
The US Food and Drug Administration (FDA) finalized its guidance for industry on the use of human factors engineering (HFE) studies to support the...
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The US Food and Drug Administration (FDA) has issued draft guidance that outlines its expectations from sponsors filing premarket submissions for patient-matched guides used...
