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Starting Feb. 1, all ventilators and personal protective equipment must meet TGA regulatory requirements and be listed on the Australian Register of Therapeutic Goods, the agency said. Read More
With the clearance, the implant system is now indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine in the C2-T1 vertebrae. Read More
Polymerase chain-reaction tests that use multiple genetic targets “are less likely to be impacted by increased prevalence of genetic variants,” TGA said. Read More
Failure to control product that did not conform to specifications, and failure to validate software landed contract manufacturer Viant AS&O Holdings in hot water with the FDA following an Oct. 20-23, 2020 inspection at the firm’s Orchard Park, New York facility. Read More
The FDA is introducing a new review program for medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or condition deemed less serious than those eligible for the breakthrough devices program. Read More
Australia’s Therapeutic Goods Administration is conducting a postmarket review of all COVID-19 point-of-care and laboratory tests listed in the Australian Register of Therapeutic Goods to ensure that they can detect emerging SARS-CoV-2 genetic variants. Read More
Complaints involving the possible failure of a device to meet any of its specifications weren’t evaluated and investigated by Medtronic’s Heart Valves Division, according to a Form 483 the firm received following an Oct. 13-26, 2020 inspection of Medtronic’s Santa Ana, California facility. Read More