Our feature exploring the myriad complications of the ongoing revision process for the international device quality systems standard ISO 13485 attracted the most "Gray Sheet" Web traffic by a long shot last month. Also popular: stories on a gap in warning letter postings; a Google device spinoff; China device reforms; and more.
August can be a quiet time when it comes to news, but there were multiple "Gray Sheet" stories that attracted significant reader attention last month.
Our feature exploring myriad complications of the ongoing revisions process for international device quality systems standard ISO 13485 was the...
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
