The FDA has recognized, for the first time, a publicly available genetic variants database that can be used to support clinical claims in diagnostic tests. Read More
Seven months after issuing a Form 483 to MiBo Medical Group following an inspection of its Dallas, Texas facility, the FDA warned the devicemaker that it had not fully addressed the problems with design control procedures, CAPA procedure... Read More
CDRH has selected eight medical devices and digital health technologies as potential solutions to help combat the growing opioid crisis in the United States. Read More
FDA inspectors found shoddy process controls and a lack of validation documentation in a Sept. 17 to Sept. 21 inspection of Footprint Medical’s San Antonio, Texas facility. Read More
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