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A March FDA inspection revealed that Bellus Medical marketed and distributed its SkinPen device without approved premarket clearance or an investigational device exemption. Read More
A federal appeals court has upheld an injunction against wholesalers’ U.S. sales of Abbott Laboratories’ “FreeStyle” blood glucose test strips that were bought overseas at discount prices. Read More
The FDA is providing guidance for devicemakers that want to coordinate development of antimicrobial susceptibility tests with sponsors developing antimicrobial drugs. Read More
Hong Kong’s Department of Health issued a warning that Medela breast pumps with detachable power plugs have been associated with the risk of electrical shock. Read More
The FDA found deficiencies in design-change procedures, validation and design verification documentation during a June inspection of InterX Technologies. Read More
Failure to submit medical device reports for its total parenteral nutrition bags landed the Metrix Company an eight-item Form 483 following a May 2016 inspection of its Dubuque, Iowa, facility. Read More