IMDRF Flags Lack of ‘Global Alignment’ in Cybersecurity
Devicemakers should assess cybersecurity risks throughout the product lifecycle, the International Medical Device Regulators Forum (IMDRF) says in a new draft guidance… Read More
FDA Investigates Implantable Devices That Contain Metals
The FDA called for feedback on a newly released report on biological responses to metal implants and says it’s investigating possible adverse events linked to the devices. Read More
Devices News
Brazil Requires Pre-Approval for Custom-Made Devices
Brazil’s ANVISA issued a new regulation for custom-made medical devices that includes new requirements for manufacturing, marketing and importing such devices. Read More
EU Medical Device Regulation Sets New Requirements for Trials
Devicemakers planning to market products in the European Union need to understand new EU rules that spell out when clinical research is required and impose requirements for conducting trials. Read More
FDA Issues Advice for Intravascular Devices With Lubricious Coatings
In a newly released guidance, the FDA spells out what manufacturers need to consider when labeling catheters, wires and delivery systems with lubricious coatings used during minimally invasive diagnostic and therapeutic vascular procedures. Read More
Wheelchair Manufacturer Warned for Misbranding
The FDA issued a warning letter to 21st Century Scientific for misbranding powered wheelchairs. Read More
