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Devices exempted from the tariffs include dental X-ray alignment and positioning apparatuses, multi-leaf collimators of radiotherapy systems, veterinary ultrasound devices and certain components of electrosurgical instruments. Read More
The agency notes that the main purpose of an IFU is to provide “detailed, action-oriented, step-by-step written and visual instructions in a patient-friendly manner.” Read More
The FDA issued a final rule on appealing CDRH’s significant decisions about medical devices, including procedures for submitting requests and timelines for the agency’s responses. Read More
The lawmakers noted that former FDA Commission Scott Gottlieb had voiced his disapproval for expanding conditional approval pathways to include human medical products. Read More