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In a postmarket study, Vasc-Alert’s surveillance technology successfully identified high-risk dialysis patients, a group seven times more likely to experience blood vessel narrowing, researchers reported in the Journal of Vascular Access.
Ceragroup Industries (CGI), a Florida manufacturer and distributer of dental porcelain products, recently received a Form 483 citing repeat problems with incomplete corrective and preventive action (CAPA) procedures and equipment lacking proper calibration.
“Real world” is a misleading and unnecessary term when it comes to data collection, says Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), who believes real-world evidence (RWE) should be treated the same as any other clinical evidence.
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.