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The studies noted that when devices cited predicates that had been subject to Class I recalls they had a much higher risk of themselves being subject to a future recall.
Failure to fully investigate complaints or to properly qualify suppliers landed devicemaker Austco Marketing and Service a Form 483 after an FDA inspection at its Irving, Texas, facility.
The overhauling of the FDA’s oversight of in vitro diagnostics will see significant movement in 2023, according to Andi Fristedt, the agency’s deputy commissioner for policy, legislation and international affairs.
Maryland-based Medcura announced that the FDA has granted the company’s LifeGel absorbable surgical hemostatic gel Breakthrough Device designation as a hemostatic agent to control bleeding during surgical procedures.