The FDA and the Department of Homeland Security signed a memorandum of agreement that expands their collaboration for medical device cybersecurity. Source: The GMP Letter

Three Democratic senators raised concerns about the FDA’s digital health pre-certification program and called for more details from the agency. Source: The GMP Letter

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. Source: The GMP…

The FDA issued a final order reclassifying the active implantable bone conduction hearing system as a Class II device with certain special controls. Source: The GMP Letter

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…

Distributors and importers that assume the obligations of device manufacturers also assume responsibility for unique device identification labeling, the European Commission said. Source: The GMP Letter

The FDA cited four devicemakers for deficiencies in their medical device reporting and other issues observed during agency inspections. Source: The GMP Letter

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…

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. Source: The…

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…