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The FDA issued an Emergency Use Authorization for a diagnostic test for the novel coronavirus linked to the ongoing outbreak that began in Wuhan, China. Read More
The FDA released final guidance on 510(k) premarket submissions for peripheral vascular atherectomy devices, outlining the information devicemakers should include in their submissions. Read More
Devicemaker Transfer Technology racked up a 12-item Form 483 covering a multitude of quality management issues following an FDA inspection of its Huntington Beach, California facility. Read More
Medegen Medical Products was cited for validation lapses and failure to control nonconforming product following an FDA inspection of its Gallaway, Tennessee plant. Read More
Labeling failures and validation lapses were among the quality system lapses uncovered during an FDA inspection of CDB Corp.’s Leland, North Carolina facility. Read More
Valeritas Holdings claimed the novel coronavirus outbreak in China, now named COVID-19, contributed to the company’s decision to file for bankruptcy. Read More
Serious quality system deficiencies that were repeat violations from a 2015 inspection landed Korean devicemaker Won Industry an FDA warning letter following an inspection of its Siheung-si, South Korea facility. Read More
The FDA has released new details of its pilot accreditation scheme for medical device conformity assessments that it expects to launch later this year. Read More
Former FDA Commissioner Scott Gottlieb warned a Senate committee of the potential for “unprecedented supply chain disruptions” as the COVID-19 outbreak threatens China’s production of components. Read More