Federal Register notice: FDA sends to OMB an information collection extension for Premarket Approval of Medical Devices.
GE Healthcare recalls the Carestation 600 Series Anesthesia Systems because there is a potential for a loose cable connection which could cause the de...
FDA announces a 3/23 public workshop on multi-component biomarker concepts and terminology.
Federal Register notice: FDA classifies human immunodeficiency virus drug resistance genotyping assays using next generation sequencing technology int...
Two U.S. senators ask FDA whether it has the necessary resources to ensure active pharmaceutical ingredients and other medical products and food impor...
FDA clears an In2Bones Global 510(k) for the Quantum Total Ankle.
FDA permits the de novo marketing of Caption Healths software to assist medical professionals in capturing cardiac ultrasound or echocardiography imag...
Becton Dickinson says FDA is requesting that modifications to the Alaris infusion pump will require a 510(k) filing.