FDA to Address ‘Narrow’ Labeling of In Vitro Companion Devices for Cancer Drugs
The way in vitro companion diagnostics for cancer drugs are labeled sometimes presents a challenge for oncology care, Commissioner Scott… Read More
Device Groups Reject Media Reports of Inadequate Oversight
International medical device associations rejected a recent report by the International Consortium of Investigative Journalists (ICIJ),… Read More
Devices News
FDA Recognizes First Human Genetic Variant Database
The FDA has recognized, for the first time, a publicly available genetic variants database that can be used to support clinical claims in diagnostic tests. Read More
FDA Warns MiBo Medical for Design Controls, CAPAs
Seven months after issuing a Form 483 to MiBo Medical Group following an inspection of its Dallas, Texas facility, the FDA warned the devicemaker that it had not fully addressed the problems with design control procedures, CAPA procedure... Read More
FDA Looks to Devices to Combat Opioid Crisis
CDRH has selected eight medical devices and digital health technologies as potential solutions to help combat the growing opioid crisis in the United States. Read More
Texas Neonatal Devicemaker Falls Short on Process Controls
FDA inspectors found shoddy process controls and a lack of validation documentation in a Sept. 17 to Sept. 21 inspection of Footprint Medical’s San Antonio, Texas facility. Read More
