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Swiss Medic will overhaul the way it issues export certificates and manufacturing certificates for devices in the fall and introduce new fees that take effect on Jan. 1, 2019. Read More
The FDA released new draft guidance for devicemakers on submitting premarket notifications for metal expandable biliary stents and their delivery systems. Read More
The FDA hit six U.S. devicemakers with 483s for problems agency investigators observed in facility inspections including inadequate risk procedures, labeling and complaint handling. Read More
IMDRF’s Adverse Event Terminology Working Group is seeking comments on proposals to harmonize terminology globally for reporting adverse events for medical devices and in vitro diagnostics. Read More
Bayer announced it would stop selling its Essure permanent birth control device after Dec. 31 and the FDA said it expects the company to meet its postmarket obligations. Read More
Brazil released its first requirements for unique device identifiers for high-risk medical devices that are slated to go into effect in 2020. Read More
In response to a request for information on medical device cybersecurity by the House Energy and Commerce Committee, stakeholders called for additional guidance and funding to help resolve cybersecurity flaws. Read More
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The FDA called for consistent coding of in vitro diagnostic tests in a new draft guidance and urged devicemakers to use Logical Observation Identifiers Names and Codes.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The FDA released draft guidance offering recommendations for information to include in labeling for devices with lubricious coating, such as intravascular catheters, guidewires, delivery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