The Senate Health, Education, Labor and Pensions Committee approved a slate of bills Feb. 9, including the Device Accountability Act, which enhances focus on the "least burdensome" concept for device review, and legislation intended to improve oversight of modified devices and device reprocessing.
A Senate panel approved seven medical product reform bills Feb. 9 by unanimous consent, including three that would affect device regulation.
The three device-relevant bills are the Device Accountability Act (S. 1622), the Preventing Superbugs and Protecting Patients Act (S. 2503)...
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.
