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. Source: The GMP Letter
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. Source: The…
Brazil released its first requirements for unique device identifiers for high-risk medical devices that are slated to go into effect in 2020. Source: The GMP Letter
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.…
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…
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…
The FDA called for consistent coding of in vitro diagnostic tests in a new draft guidance and urged devicemakers to use Logical Observation Identifiers Names and Codes. Source: The GMP…
The FDA released draft guidance offering recommendations for information to include in labeling for devices with lubricious coating, such as intravascular catheters, guidewires, delivery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. Source:…
The FDA cited six devicemakers for numerous violations including issues with CAPAs, training, MDRs, complaint handling, improper calibration and validation procedures. Source: The GMP Letter
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…