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Fujifilm Medical Systems U.S.A., Inc. failed to investigate complaints about a device failure, establish procedures for evaluating complaints and taking corrective and preventive action, fail report a correction or removal, and adequately validate a process, according to a Form 483. Read More
Failure to report a design change and to conduct proper design validation for its porcine xenograft particulate in syringe landed Collagen Matrix an FDA warning letter. Read More
The FDA has released draft guidance on product labeling for ultrasonic surgical aspirator devices that it says will contribute to their safe and effective use. Read More
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