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FDA Commissioner Robert Califf laid out his priorities for “a major reformation of our national system for generating medical evidence” and wearable sensors were at the top of his list, in an article in the journal Clinical Trials. Read More
The SEIU-United Healthcare Workers West union in California has petitioned the FDA to issue corrective recalls for Fresenius 2008K2, 2008T, and 2008T BlueStar hemodialysis machines to protect patients from high ultrafiltration rates and assure accurate conductivity — concentration of dialysis fluid.
The FDA has sent Surmodics a Complete Response Letter for its SurVeil drug-coated balloon, asking the company to amend its premarket approval application (PMA) to add information on biocompatibility and labeling.
In a letter to the White House, AdvaMed defended the medical sterilization industry’s use of ethylene oxide (EtO) and asked for consideration of several points for the Environmental Protection Agency’s (EPA) proposed regulation of the sterilization process for medical devices.
The FDA has released a final rule on radiological health that revises documentation requirements, allowing more time for submitting reports for accidental radiation occurrences (AROs).
The FDA has granted a priority review for Purdue’s abbreviated new drug application for nalmefene prefilled syringes for complete or partial reversal of opioid overdose.
The FDA has called for suggestions for how it should make use of user fee funding for two data reporting projects — premarket real-world evidence (RWE) activities and the Medical Product Safety Network (MedSun) program, a national surveillance network to collect postmarket data on medical devices.