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The firm’s medical device reporting procedures did not include a system for timely identification and evaluation of reportable events, the agency said. Read More
Some individuals “may be predisposed to develop a local or systemic immune or inflammatory reaction when exposed to certain metals contained in select implantable devices,” the agency said. Read More
An accredited testing lab may conduct testing to determine conformance of a device with at least one of the standards eligible for inclusion in the ASCA pilot. Read More