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The FDA is considering a total product lifecycle monitoring approach to emerging artificial intelligence devices, the agency said in a proposed regulatory framework. Read More
A trade group representing hybrid drug- and device-makers is urging the FDA to draw bright lines among the agency’s centers as it considers voluntary quality standards. Read More
The FDA issued a draft guidance and proposed order designed to ensure the safe and effective use of surgical staplers and staples for internal use. Read More
The European Commission released long-awaited guidance on Eudamed (the European Database on Medical Devices) and the device nomenclature system that will be used for the EU’s new medical device and in vitro diagnostic regulations. Read More
MedTech Europe is warning European regulators that the EU’s new regulatory system for devices won’t be ready on time and said the delay will jeopardize patient lives. Read More
“We believe these steps for more transparent medical device reports will contribute to greater public awareness of breast implant adverse events,” the agency said. Read More