We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Some devicemakers will be allowed to continue placing their products on the EU market while they deal with the unexpected withdrawal of a notified body, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said. Read More
The FDA has released new details of its pilot accreditation scheme for medical device conformity assessments that it expects to launch later this year. Read More
The FDA cited six devicemakers for a range of GMP and other failures, including root-cause analysis for nonconforming products and lax environmental controls. Read More
The FDA released draft guidance for devicemakers on 510(k) submissions for catheter-based devices intended to treat peripheral vasculature lesions, including suggestions on labeling and performance testing. Read More
The FDA slapped Henan Kangdi Medical Devices with a warning letter over repeat CGMP failures at its Zhoukou, Henan facility, including a lack of testing. Read More
The EU’s Medical Device Coordination Group released new guidance on cybersecurity requirements for devicemakers under the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Read More
Health Canada has finalized guidance on software as a medical device (SaMD) that clarifies how it fits into the agency’s regulatory framework and how devicemakers can comply. Read More
The Federal Court of Australia has found Johnson & Johnson responsible in a lawsuit by more than 1,350 women over injuries linked to failures of its pelvic mesh. Read More
Health Canada is creating a stand-alone Medical Devices Directorate (MDD) within its Health Products and Food Branch that will take a “lifecycle approach” and also take on postmarket functions currently within the Marketed Health Products Directorate. Read More