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The FDA and the Department of Homeland Security signed a memorandum of agreement that expands their collaboration for medical device cybersecurity. Read More
Three Democratic senators raised concerns about the FDA’s digital health pre-certification program and called for more details from the agency. Read More
To give a reasonable assurance of safety and efficacy of high flow humidified oxygen delivery devices, the FDA reclassified them into Class II and identified special controls. Read More
The FDA issued a final order reclassifying the active implantable bone conduction hearing system as a Class II device with certain special controls. Read More
The FDA flagged cybersecurity vulnerabilities in two implantable cardiac device programmers manufactured by Medtronic and approved a software update that will allow providers to continue using the programmers without connecting to the internet. Read More
Distributors and importers that assume the obligations of device manufacturers also assume responsibility for unique device identification labeling, the European Commission said. Read More
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