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Allergan recalled its Ozurdex 700 mg intravitreal implant because a single loose silicone particle may become detached from the needle sleeve during administration of the implant and may be delivered into the eye along with the implant. Read More
The FDA issued final guidance on “single-dose” and “multiple-dose” containers for injectable medical products — introducing a new term “single-patient use.” Read More
In a warning letter to Becton Dickinson Medical System, the FDA said the devicemaker must further document its corrections to problems with environmental conditions and safeguards against contamination. Read More
Health Canada said some devicemakers may cancel their licenses and discontinue selling their products in Canada rather than conform to the new Medical Device Single Audit Program requirements. Read More
The FDA released guidance for sponsors of devices with cybersecurity risks on what they should include in their premarket submissions, as well as considerations for device design and labeling. Read More
Boston Scientific and Cook Medical questioned parts of the FDA’s guidance on premarket notifications for metal expandable biliary stents and their delivery systems — including limits on eligibility for the Special 510(k) program and some recommended test methods in the agency’s draft released in July. Read More
The FDA flagged six devicemakers for a variety of deficiencies including complaint handling, inadequate documentation and quality system failures. Read More
ITG-Medev failed to follow up on its promised solutions to nonconforming process validations and documentation of acceptance activities, the FDA said in a warning letter to the devicemaker. Read More