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France’s National Agency for the Safety of Medicines (ANSM) is calling for more exhaustive clinical studies prior to CE marking of flow diverter stents that are implanted to treat intracranial aneurysms. Read More
The FDA called for consistent coding of in vitro diagnostic tests in a new draft guidance and urged devicemakers to use Logical Observation Identifiers Names and Codes. Read More
The FDA cited six devicemakers for numerous violations including issues with CAPAs, training, MDRs, complaint handling, improper calibration and validation procedures. Read More
The FDA released draft guidance offering recommendations for information to include in labeling for devices with lubricious coating, such as intravascular catheters, guidewires, delivery sheaths and implant delivery systems. Read More
One year after the EU finalized its new medical device and in vitro diagnostics regulations there has been little progress in helping industry transition to the new regulations, according to MedTech Europe. Read More
The FDA released version 0.2 of its Developing Software Precertification Program intended to allow the agency to more efficiently approve software as a medical device (SaMD) without risking patient health and safety. Read More
The FDA put out a list of alternative ways to comply with quality system requirements for device combination products, making suggestions for design controls and quality system regulation exemptions. Read More